MyHealth@Eu Laboratory Report
0.0.1 - qa-preview 150

This page is part of the MyHealth@Eu Laboratory Report (v0.0.1: QA Preview) based on FHIR (HL7® FHIR® Standard) R4. This is the current published version. For a full list of available versions, see the Directory of published versions

Resource Profile: DeviceSpecimenMyHealthEu - Detailed Descriptions

Draft as of 2024-04-18

Definitions for the Device-specimen-lab-myhealtheu resource profile.

Guidance on how to interpret the contents of this table can be found here

0. Device
2. Device.identifier
NoteThis is a business identifier, not a resource identifier (see discussion)
Obligations
    ObligationsActor
    handleLabReportHandler
    4. Device.udiCarrier
    Obligations
      ObligationsActor
      handleLabReportHandler
      6. Device.manufacturer
      Obligations
        ObligationsActor
        handleLabReportHandler
        handleLabReportHandler
        8. Device.deviceName
        10. Device.deviceName.name
        Obligations
          ObligationsActor
          handleLabReportHandler
          12. Device.type
          ShortThe type of device
          BindingThe codes SHALL be taken from eHDSI Medical Device with exceptions
          (required to http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSIMedicalDeviceWithExceptions)
          Obligations
            ObligationsActor
            handleLabReportHandler

            Guidance on how to interpret the contents of this table can be found here

            0. Device
            Definition

            A type of a manufactured item that is used in the provision of healthcare without being substantially changed through that activity. The device may be a medical or non-medical device.

            ShortItem used in healthcare
            Control0..*
            Is Modifierfalse
            Summaryfalse
            Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
            dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty())
            dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
            dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
            dom-6: A resource should have narrative for robust management (text.`div`.exists())
            2. Device.implicitRules
            Definition

            A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

            ShortA set of rules under which this content was created
            Comments

            Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.

            Control0..1
            Typeuri
            Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            4. Device.modifierExtension
            Definition

            May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

            Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

            ShortExtensions that cannot be ignored
            Comments

            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

            Control0..*
            TypeExtension
            Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
            Summaryfalse
            Requirements

            Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

            Alternate Namesextensions, user content
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            6. Device.identifier
            Definition

            Unique instance identifiers assigned to a device by manufacturers other organizations or owners.

            ShortInstance identifier
            Comments

            The barcode string from a barcode present on a device label or package may identify the instance, include names given to the device in local usage, or may identify the type of device. If the identifier identifies the type of device, Device.type element should be used.

            NoteThis is a business identifier, not a resource identifier (see discussion)
            Control0..*
            TypeIdentifier
            Is Modifierfalse
            Obligations
              ObligationsActor
              handleLabReportHandler
              Summaryfalse
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              8. Device.udiCarrier
              Definition

              Unique device identifier (UDI) assigned to device label or package. Note that the Device may include multiple udiCarriers as it either may include just the udiCarrier for the jurisdiction it is sold, or for multiple jurisdictions it could have been sold.

              ShortUnique Device Identifier (UDI) Barcode string
              Comments

              UDI may identify an unique instance of a device, or it may only identify the type of the device. See UDI mappings for a complete mapping of UDI parts to Device.

              Control0..*
              TypeBackboneElement
              Is Modifierfalse
              Obligations
                ObligationsActor
                handleLabReportHandler
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                10. Device.udiCarrier.modifierExtension
                Definition

                May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                ShortExtensions that cannot be ignored even if unrecognized
                Comments

                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                Control0..*
                TypeExtension
                Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                Summarytrue
                Requirements

                Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                Alternate Namesextensions, user content, modifiers
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                12. Device.status
                Definition

                Status of the Device availability.

                Shortactive | inactive | entered-in-error | unknown
                Comments

                This element is labeled as a modifier because the status contains the codes inactive and entered-in-error that mark the device (record)as not currently valid.

                Control0..1
                BindingThe codes SHALL be taken from FHIRDeviceStatushttp://hl7.org/fhir/ValueSet/device-status|4.0.1
                (required to http://hl7.org/fhir/ValueSet/device-status|4.0.1)

                The availability status of the device.

                Typecode
                Is Modifiertrue because This element is labelled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid
                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                14. Device.manufacturer
                Definition

                A name of the manufacturer.

                ShortName of device manufacturer
                Control0..1
                Typestring
                Is Modifierfalse
                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                Obligations
                  ObligationsActor
                  handleLabReportHandler
                  handleLabReportHandler
                  Summaryfalse
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  16. Device.type
                  Definition

                  The kind or type of device.

                  ShortThe type of deviceThe kind or type of device
                  Control0..1
                  BindingThe codes SHALL be taken from For example codes, see eHDSI Medical Device with exceptionshttp://hl7.org/fhir/ValueSet/device-type
                  (required to http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSIMedicalDeviceWithExceptions)
                  TypeCodeableConcept
                  Is Modifierfalse
                  Obligations
                    ObligationsActor
                    handleLabReportHandler
                    Summaryfalse
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

                    Guidance on how to interpret the contents of this table can be found here

                    0. Device
                    Definition

                    A type of a manufactured item that is used in the provision of healthcare without being substantially changed through that activity. The device may be a medical or non-medical device.

                    ShortItem used in healthcare
                    Control0..*
                    Is Modifierfalse
                    Summaryfalse
                    Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
                    dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty())
                    dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
                    dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
                    dom-6: A resource should have narrative for robust management (text.`div`.exists())
                    2. Device.id
                    Definition

                    The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

                    ShortLogical id of this artifact
                    Comments

                    The only time that a resource does not have an id is when it is being submitted to the server using a create operation.

                    Control0..1
                    Typeid
                    Is Modifierfalse
                    Summarytrue
                    4. Device.meta
                    Definition

                    The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.

                    ShortMetadata about the resource
                    Control0..1
                    TypeMeta
                    Is Modifierfalse
                    Summarytrue
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    6. Device.implicitRules
                    Definition

                    A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

                    ShortA set of rules under which this content was created
                    Comments

                    Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.

                    Control0..1
                    Typeuri
                    Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation
                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                    Summarytrue
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    8. Device.language
                    Definition

                    The base language in which the resource is written.

                    ShortLanguage of the resource content
                    Comments

                    Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).

                    Control0..1
                    BindingThe codes SHOULD be taken from CommonLanguages
                    (preferred to http://hl7.org/fhir/ValueSet/languages)

                    A human language.

                    Additional BindingsPurpose
                    AllLanguagesMax Binding
                    Typecode
                    Is Modifierfalse
                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                    Summaryfalse
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    10. Device.text
                    Definition

                    A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.

                    ShortText summary of the resource, for human interpretation
                    Comments

                    Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.

                    Control0..1
                    TypeNarrative
                    Is Modifierfalse
                    Summaryfalse
                    Alternate Namesnarrative, html, xhtml, display
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    12. Device.contained
                    Definition

                    These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.

                    ShortContained, inline Resources
                    Comments

                    This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels.

                    Control0..*
                    TypeResource
                    Is Modifierfalse
                    Summaryfalse
                    Alternate Namesinline resources, anonymous resources, contained resources
                    14. Device.extension
                    Definition

                    May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                    ShortAdditional content defined by implementations
                    Comments

                    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                    Control0..*
                    TypeExtension
                    Is Modifierfalse
                    Summaryfalse
                    Alternate Namesextensions, user content
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                    16. Device.modifierExtension
                    Definition

                    May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                    Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                    ShortExtensions that cannot be ignored
                    Comments

                    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                    Control0..*
                    TypeExtension
                    Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
                    Summaryfalse
                    Requirements

                    Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                    Alternate Namesextensions, user content
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                    18. Device.identifier
                    Definition

                    Unique instance identifiers assigned to a device by manufacturers other organizations or owners.

                    ShortInstance identifier
                    Comments

                    The barcode string from a barcode present on a device label or package may identify the instance, include names given to the device in local usage, or may identify the type of device. If the identifier identifies the type of device, Device.type element should be used.

                    NoteThis is a business identifier, not a resource identifier (see discussion)
                    Control0..*
                    TypeIdentifier
                    Is Modifierfalse
                    Obligations
                      ObligationsActor
                      handleLabReportHandler
                      Summaryfalse
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      20. Device.definition
                      Definition

                      The reference to the definition for the device.

                      ShortThe reference to the definition for the device
                      Control0..1
                      TypeReference(DeviceDefinition)
                      Is Modifierfalse
                      Summaryfalse
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      22. Device.udiCarrier
                      Definition

                      Unique device identifier (UDI) assigned to device label or package. Note that the Device may include multiple udiCarriers as it either may include just the udiCarrier for the jurisdiction it is sold, or for multiple jurisdictions it could have been sold.

                      ShortUnique Device Identifier (UDI) Barcode string
                      Comments

                      UDI may identify an unique instance of a device, or it may only identify the type of the device. See UDI mappings for a complete mapping of UDI parts to Device.

                      Control0..*
                      TypeBackboneElement
                      Is Modifierfalse
                      Obligations
                        ObligationsActor
                        handleLabReportHandler
                        Summarytrue
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        24. Device.udiCarrier.id
                        Definition

                        Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                        ShortUnique id for inter-element referencing
                        Control0..1
                        Typestring
                        Is Modifierfalse
                        XML FormatIn the XML format, this property is represented as an attribute.
                        Summaryfalse
                        26. Device.udiCarrier.extension
                        Definition

                        May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                        ShortAdditional content defined by implementations
                        Comments

                        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                        Control0..*
                        TypeExtension
                        Is Modifierfalse
                        Summaryfalse
                        Alternate Namesextensions, user content
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                        28. Device.udiCarrier.modifierExtension
                        Definition

                        May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                        Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                        ShortExtensions that cannot be ignored even if unrecognized
                        Comments

                        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                        Control0..*
                        TypeExtension
                        Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                        Summarytrue
                        Requirements

                        Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                        Alternate Namesextensions, user content, modifiers
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                        30. Device.udiCarrier.deviceIdentifier
                        Definition

                        The device identifier (DI) is a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device.

                        ShortMandatory fixed portion of UDI
                        Control0..1
                        Typestring
                        Is Modifierfalse
                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                        Summarytrue
                        Alternate NamesDI
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        32. Device.udiCarrier.issuer
                        Definition

                        Organization that is charged with issuing UDIs for devices. For example, the US FDA issuers include :

                        1. GS1: http://hl7.org/fhir/NamingSystem/gs1-di,
                        2. HIBCC: http://hl7.org/fhir/NamingSystem/hibcc-dI,
                        3. ICCBBA for blood containers: http://hl7.org/fhir/NamingSystem/iccbba-blood-di,
                        4. ICCBA for other devices: http://hl7.org/fhir/NamingSystem/iccbba-other-di.
                        ShortUDI Issuing Organization
                        Control0..1
                        Typeuri
                        Is Modifierfalse
                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                        Summaryfalse
                        Alternate NamesBarcode System
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        34. Device.udiCarrier.jurisdiction
                        Definition

                        The identity of the authoritative source for UDI generation within a jurisdiction. All UDIs are globally unique within a single namespace with the appropriate repository uri as the system. For example, UDIs of devices managed in the U.S. by the FDA, the value is http://hl7.org/fhir/NamingSystem/fda-udi.

                        ShortRegional UDI authority
                        Control0..1
                        Typeuri
                        Is Modifierfalse
                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                        Summaryfalse
                        Requirements

                        Allows a recipient of a UDI to know which database will contain the UDI-associated metadata.

                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        36. Device.udiCarrier.carrierAIDC
                        Definition

                        The full UDI carrier of the Automatic Identification and Data Capture (AIDC) technology representation of the barcode string as printed on the packaging of the device - e.g., a barcode or RFID. Because of limitations on character sets in XML and the need to round-trip JSON data through XML, AIDC Formats SHALL be base64 encoded.

                        ShortUDI Machine Readable Barcode String
                        Comments

                        The AIDC form of UDIs should be scanned or otherwise used for the identification of the device whenever possible to minimize errors in records resulting from manual transcriptions. If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label.

                        Control0..1
                        Typebase64Binary
                        Is Modifierfalse
                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                        Summarytrue
                        Alternate NamesAutomatic Identification and Data Capture
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        38. Device.udiCarrier.carrierHRF
                        Definition

                        The full UDI carrier as the human readable form (HRF) representation of the barcode string as printed on the packaging of the device.

                        ShortUDI Human Readable Barcode String
                        Comments

                        If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label.

                        Control0..1
                        Typestring
                        Is Modifierfalse
                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                        Summarytrue
                        Alternate NamesHuman Readable Form
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        40. Device.udiCarrier.entryType
                        Definition

                        A coded entry to indicate how the data was entered.

                        Shortbarcode | rfid | manual +
                        Control0..1
                        BindingThe codes SHALL be taken from UDIEntryType
                        (required to http://hl7.org/fhir/ValueSet/udi-entry-type|4.0.1)

                        Codes to identify how UDI data was entered.

                        Typecode
                        Is Modifierfalse
                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                        Summaryfalse
                        Requirements

                        Supports a way to distinguish hand entered from machine read data.

                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        42. Device.status
                        Definition

                        Status of the Device availability.

                        Shortactive | inactive | entered-in-error | unknown
                        Comments

                        This element is labeled as a modifier because the status contains the codes inactive and entered-in-error that mark the device (record)as not currently valid.

                        Control0..1
                        BindingThe codes SHALL be taken from FHIRDeviceStatus
                        (required to http://hl7.org/fhir/ValueSet/device-status|4.0.1)

                        The availability status of the device.

                        Typecode
                        Is Modifiertrue because This element is labelled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid
                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                        Summarytrue
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        44. Device.statusReason
                        Definition

                        Reason for the dtatus of the Device availability.

                        Shortonline | paused | standby | offline | not-ready | transduc-discon | hw-discon | off
                        Control0..*
                        BindingUnless not suitable, these codes SHALL be taken from FHIRDeviceStatusReason
                        (extensible to http://hl7.org/fhir/ValueSet/device-status-reason)

                        The availability status reason of the device.

                        TypeCodeableConcept
                        Is Modifierfalse
                        Summaryfalse
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        46. Device.distinctIdentifier
                        Definition

                        The distinct identification string as required by regulation for a human cell, tissue, or cellular and tissue-based product.

                        ShortThe distinct identification string
                        Comments

                        For example, this applies to devices in the United States regulated under Code of Federal Regulation 21CFR§1271.290(c).

                        Control0..1
                        Typestring
                        Is Modifierfalse
                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                        Summaryfalse
                        Alternate NamesDistinct Identification Code (DIC)
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        48. Device.manufacturer
                        Definition

                        A name of the manufacturer.

                        ShortName of device manufacturer
                        Control0..1
                        Typestring
                        Is Modifierfalse
                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                        Obligations
                          ObligationsActor
                          handleLabReportHandler
                          handleLabReportHandler
                          Summaryfalse
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          50. Device.manufactureDate
                          Definition

                          The date and time when the device was manufactured.

                          ShortDate when the device was made
                          Control0..1
                          TypedateTime
                          Is Modifierfalse
                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                          Summaryfalse
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          52. Device.expirationDate
                          Definition

                          The date and time beyond which this device is no longer valid or should not be used (if applicable).

                          ShortDate and time of expiry of this device (if applicable)
                          Control0..1
                          TypedateTime
                          Is Modifierfalse
                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                          Summaryfalse
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          54. Device.lotNumber
                          Definition

                          Lot number assigned by the manufacturer.

                          ShortLot number of manufacture
                          Control0..1
                          Typestring
                          Is Modifierfalse
                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                          Summaryfalse
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          56. Device.serialNumber
                          Definition

                          The serial number assigned by the organization when the device was manufactured.

                          ShortSerial number assigned by the manufacturer
                          Comments

                          Alphanumeric Maximum 20.

                          Control0..1
                          Typestring
                          Is Modifierfalse
                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                          Summaryfalse
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          58. Device.deviceName
                          Definition

                          This represents the manufacturer's name of the device as provided by the device, from a UDI label, or by a person describing the Device. This typically would be used when a person provides the name(s) or when the device represents one of the names available from DeviceDefinition.

                          ShortThe name of the device as given by the manufacturer
                          Control0..*
                          TypeBackboneElement
                          Is Modifierfalse
                          Summaryfalse
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          60. Device.deviceName.id
                          Definition

                          Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                          ShortUnique id for inter-element referencing
                          Control0..1
                          Typestring
                          Is Modifierfalse
                          XML FormatIn the XML format, this property is represented as an attribute.
                          Summaryfalse
                          62. Device.deviceName.extension
                          Definition

                          May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                          ShortAdditional content defined by implementations
                          Comments

                          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                          Control0..*
                          TypeExtension
                          Is Modifierfalse
                          Summaryfalse
                          Alternate Namesextensions, user content
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                          64. Device.deviceName.modifierExtension
                          Definition

                          May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                          Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                          ShortExtensions that cannot be ignored even if unrecognized
                          Comments

                          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                          Control0..*
                          TypeExtension
                          Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                          Summarytrue
                          Requirements

                          Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                          Alternate Namesextensions, user content, modifiers
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                          66. Device.deviceName.name
                          Definition

                          The name of the device.

                          ShortThe name of the device
                          Control1..1
                          Typestring
                          Is Modifierfalse
                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                          Obligations
                            ObligationsActor
                            handleLabReportHandler
                            Summaryfalse
                            Alternate NamesΣ
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            68. Device.deviceName.type
                            Definition

                            The type of deviceName. UDILabelName | UserFriendlyName | PatientReportedName | ManufactureDeviceName | ModelName.

                            Shortudi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other
                            Control1..1
                            BindingThe codes SHALL be taken from DeviceNameType
                            (required to http://hl7.org/fhir/ValueSet/device-nametype|4.0.1)

                            The type of name the device is referred by.

                            Typecode
                            Is Modifierfalse
                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                            Summaryfalse
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            70. Device.modelNumber
                            Definition

                            The model number for the device.

                            ShortThe model number for the device
                            Control0..1
                            Typestring
                            Is Modifierfalse
                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                            Summaryfalse
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            72. Device.partNumber
                            Definition

                            The part number of the device.

                            ShortThe part number of the device
                            Comments

                            Alphanumeric Maximum 20.

                            Control0..1
                            Typestring
                            Is Modifierfalse
                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                            Summaryfalse
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            74. Device.type
                            Definition

                            The kind or type of device.

                            ShortThe type of device
                            Control0..1
                            BindingThe codes SHALL be taken from eHDSI Medical Device with exceptions
                            (required to http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSIMedicalDeviceWithExceptions)
                            TypeCodeableConcept
                            Is Modifierfalse
                            Obligations
                              ObligationsActor
                              handleLabReportHandler
                              Summaryfalse
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              76. Device.specialization
                              Definition

                              The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication.

                              ShortThe capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication
                              Control0..*
                              TypeBackboneElement
                              Is Modifierfalse
                              Summaryfalse
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              78. Device.specialization.id
                              Definition

                              Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                              ShortUnique id for inter-element referencing
                              Control0..1
                              Typestring
                              Is Modifierfalse
                              XML FormatIn the XML format, this property is represented as an attribute.
                              Summaryfalse
                              80. Device.specialization.extension
                              Definition

                              May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                              ShortAdditional content defined by implementations
                              Comments

                              There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                              Control0..*
                              TypeExtension
                              Is Modifierfalse
                              Summaryfalse
                              Alternate Namesextensions, user content
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                              82. Device.specialization.modifierExtension
                              Definition

                              May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                              Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                              ShortExtensions that cannot be ignored even if unrecognized
                              Comments

                              There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                              Control0..*
                              TypeExtension
                              Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                              Summarytrue
                              Requirements

                              Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                              Alternate Namesextensions, user content, modifiers
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                              84. Device.specialization.systemType
                              Definition

                              The standard that is used to operate and communicate.

                              ShortThe standard that is used to operate and communicate
                              Control1..1
                              TypeCodeableConcept
                              Is Modifierfalse
                              Summaryfalse
                              Alternate NamesΣ
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              86. Device.specialization.version
                              Definition

                              The version of the standard that is used to operate and communicate.

                              ShortThe version of the standard that is used to operate and communicate
                              NoteThis is a business versionId, not a resource version id (see discussion)
                              Control0..1
                              Typestring
                              Is Modifierfalse
                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                              Summaryfalse
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              88. Device.version
                              Definition

                              The actual design of the device or software version running on the device.

                              ShortThe actual design of the device or software version running on the device
                              NoteThis is a business versionId, not a resource version id (see discussion)
                              Control0..*
                              TypeBackboneElement
                              Is Modifierfalse
                              Summaryfalse
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              90. Device.version.id
                              Definition

                              Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                              ShortUnique id for inter-element referencing
                              Control0..1
                              Typestring
                              Is Modifierfalse
                              XML FormatIn the XML format, this property is represented as an attribute.
                              Summaryfalse
                              92. Device.version.extension
                              Definition

                              May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                              ShortAdditional content defined by implementations
                              Comments

                              There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                              Control0..*
                              TypeExtension
                              Is Modifierfalse
                              Summaryfalse
                              Alternate Namesextensions, user content
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                              94. Device.version.modifierExtension
                              Definition

                              May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                              Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                              ShortExtensions that cannot be ignored even if unrecognized
                              Comments

                              There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                              Control0..*
                              TypeExtension
                              Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                              Summarytrue
                              Requirements

                              Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                              Alternate Namesextensions, user content, modifiers
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                              96. Device.version.type
                              Definition

                              The type of the device version.

                              ShortThe type of the device version
                              Control0..1
                              TypeCodeableConcept
                              Is Modifierfalse
                              Summaryfalse
                              Alternate NamesΣ
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              98. Device.version.component
                              Definition

                              A single component of the device version.

                              ShortA single component of the device version
                              Control0..1
                              TypeIdentifier
                              Is Modifierfalse
                              Summaryfalse
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              100. Device.version.value
                              Definition

                              The version text.

                              ShortThe version text
                              Control1..1
                              Typestring
                              Is Modifierfalse
                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                              Summaryfalse
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              102. Device.property
                              Definition

                              The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties.

                              ShortThe actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
                              Control0..*
                              TypeBackboneElement
                              Is Modifierfalse
                              Summaryfalse
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              104. Device.property.id
                              Definition

                              Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                              ShortUnique id for inter-element referencing
                              Control0..1
                              Typestring
                              Is Modifierfalse
                              XML FormatIn the XML format, this property is represented as an attribute.
                              Summaryfalse
                              106. Device.property.extension
                              Definition

                              May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                              ShortAdditional content defined by implementations
                              Comments

                              There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                              Control0..*
                              TypeExtension
                              Is Modifierfalse
                              Summaryfalse
                              Alternate Namesextensions, user content
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                              108. Device.property.modifierExtension
                              Definition

                              May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                              Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                              ShortExtensions that cannot be ignored even if unrecognized
                              Comments

                              There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                              Control0..*
                              TypeExtension
                              Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                              Summarytrue
                              Requirements

                              Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                              Alternate Namesextensions, user content, modifiers
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                              110. Device.property.type
                              Definition

                              Code that specifies the property DeviceDefinitionPropetyCode (Extensible).

                              ShortCode that specifies the property DeviceDefinitionPropetyCode (Extensible)
                              Control1..1
                              TypeCodeableConcept
                              Is Modifierfalse
                              Summaryfalse
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              112. Device.property.valueQuantity
                              Definition

                              Property value as a quantity.

                              ShortProperty value as a quantity
                              Control0..*
                              TypeQuantity
                              Is Modifierfalse
                              Summaryfalse
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              114. Device.property.valueCode
                              Definition

                              Property value as a code, e.g., NTP4 (synced to NTP).

                              ShortProperty value as a code, e.g., NTP4 (synced to NTP)
                              Control0..*
                              TypeCodeableConcept
                              Is Modifierfalse
                              Summaryfalse
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              116. Device.patient
                              Definition

                              Patient information, If the device is affixed to a person.

                              ShortPatient to whom Device is affixed
                              Control0..1
                              TypeReference(Patient)
                              Is Modifierfalse
                              Summaryfalse
                              Requirements

                              If the device is implanted in a patient, then need to associate the device to the patient.

                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              118. Device.owner
                              Definition

                              An organization that is responsible for the provision and ongoing maintenance of the device.

                              ShortOrganization responsible for device
                              Control0..1
                              TypeReference(Organization)
                              Is Modifierfalse
                              Summaryfalse
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              120. Device.contact
                              Definition

                              Contact details for an organization or a particular human that is responsible for the device.

                              ShortDetails for human/organization for support
                              Comments

                              used for troubleshooting etc.

                              Control0..*
                              TypeContactPoint
                              Is Modifierfalse
                              Summaryfalse
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              122. Device.location
                              Definition

                              The place where the device can be found.

                              ShortWhere the device is found
                              Control0..1
                              TypeReference(Location)
                              Is Modifierfalse
                              Summaryfalse
                              Requirements

                              Device.location can be used to track device location.

                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              124. Device.url
                              Definition

                              A network address on which the device may be contacted directly.

                              ShortNetwork address to contact device
                              Comments

                              If the device is running a FHIR server, the network address should be the Base URL from which a conformance statement may be retrieved.

                              Control0..1
                              Typeuri
                              Is Modifierfalse
                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                              Summaryfalse
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              126. Device.note
                              Definition

                              Descriptive information, usage information or implantation information that is not captured in an existing element.

                              ShortDevice notes and comments
                              Control0..*
                              TypeAnnotation
                              Is Modifierfalse
                              Summaryfalse
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              128. Device.safety
                              Definition

                              Provides additional safety characteristics about a medical device. For example devices containing latex.

                              ShortSafety Characteristics of Device
                              Control0..*
                              TypeCodeableConcept
                              Is Modifierfalse
                              Summarytrue
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              130. Device.parent
                              Definition

                              The parent device.

                              ShortThe parent device
                              Control0..1
                              TypeReference(Device)
                              Is Modifierfalse
                              Summaryfalse
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))