Consolidated CDA Release 2.1 StructureDefinition Publication
2.1 - CI Build United States of America flag

Consolidated CDA Release 2.1 StructureDefinition Publication, published by Health Level Seven. This is not an authorized publication; it is the continuous build for version 2.1). This version is based on the current content of https://github.com/HL7/CDA-ccda-2.1-sd/ and changes regularly. See the Directory of published versions

Logical Model: Device Identifier Observation

Official URL: http://hl7.org/cda/us/ccda/StructureDefinition/DeviceIdentifierObservation Version: 2.1
Draft as of 2023-09-29 Computable Name: DeviceIdentifierObservation
Other Identifiers: id: urn:hl7ii:2.16.840.1.113883.10.20.22.4.304:2022-06-01

This template is intended to be used in addition to the Product Instance template urn:oid:2.16.840.1.113883.10.20.22.4.37 to exchange the Device Identifier (also known as the “Primary DI Number”) for a medical device marketed in the US. The device identifier is parsed from the UDI value.

The Device Identifier number can be used as a key to look-up device identification information in the publicly available version of the US FDA Global UDI Database (GUDID) - the AccessGUDID: https://accessgudid.nlm.nih.gov/resources/home

Usage:

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

This structure is derived from CDAR2.Observation

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation 1..1CDAR2.ObservationXML Namespace: urn:hl7-org:v3
Elements defined in Ancestors: @classCode, @moodCode, @negationInd, realmCode, typeId, templateId, id, code, derivationExpr, text, statusCode, effectiveTime, priorityCode, repeatNumber, languageCode, value, interpretationCode, methodCode, targetSiteCode, subject, specimen, performer, author, informant, participant, entryRelationship, reference, precondition, referenceRange
Base for all types and resources
... templateId 1..1II
.... root 1..1oid, uuid, ruidRequired Pattern: 2.16.840.1.113883.10.20.22.4.304
.... extension 1..1stRequired Pattern: 2022-06-01
... code 1..1CDPrimary DI Number Code from NCIt
.... code 1..1csRequired Pattern: C101722
.... codeSystem 1..1oid, uuid, ruidRequired Pattern: 2.16.840.1.113883.3.26.1.1
.... codeSystemName 0..1stRequired Pattern: NCI Thesaurus
.... displayName 0..1stRequired Pattern: Primary DI Number
... value 1..1IIThis value is assigned by the Manufacturer by using an FDA-accredited UDI-issuing agency
.... displayable 1..1bl
.... root 1..1oid, uuid, ruid
.... extension 0..1st

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation 1..1CDAR2.ObservationXML Namespace: urn:hl7-org:v3
Elements defined in Ancestors: @classCode, @moodCode, @negationInd, realmCode, typeId, templateId, id, code, derivationExpr, text, statusCode, effectiveTime, priorityCode, repeatNumber, languageCode, value, interpretationCode, methodCode, targetSiteCode, subject, specimen, performer, author, informant, participant, entryRelationship, reference, precondition, referenceRange
Base for all types and resources
... @classCode 1..1csBinding: ActClassObservation (required)
... @moodCode 1..1cs
... templateId 1..1II
.... @root 1..1oid, uuid, ruidRequired Pattern: 2.16.840.1.113883.10.20.22.4.304
.... @extension 1..1stRequired Pattern: 2022-06-01
.... @code 1..1csRequired Pattern: C101722
.... @codeSystem 1..1oid, uuid, ruidRequired Pattern: 2.16.840.1.113883.3.26.1.1
.... @codeSystemName 0..1stRequired Pattern: NCI Thesaurus
.... @displayName 0..1stRequired Pattern: Primary DI Number
... value 1..1IIThis value is assigned by the Manufacturer by using an FDA-accredited UDI-issuing agency
.... @displayable 1..1bl
.... @root 1..1oid, uuid, ruid
.... @extension 0..1st

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet
Observation.classCoderequiredActClassObservation
Observation.codeextensibleObservationType

Constraints

IdGradePath(s)DetailsRequirements
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation 1..1CDAR2.ObservationXML Namespace: urn:hl7-org:v3
Elements defined in Ancestors: @classCode, @moodCode, @negationInd, realmCode, typeId, templateId, id, code, derivationExpr, text, statusCode, effectiveTime, priorityCode, repeatNumber, languageCode, value, interpretationCode, methodCode, targetSiteCode, subject, specimen, performer, author, informant, participant, entryRelationship, reference, precondition, referenceRange
Base for all types and resources
... @classCode 1..1csBinding: ActClassObservation (required)
... @moodCode 1..1cs
... @negationInd 0..1bl
... realmCode 0..*CS
... typeId 0..1II
... templateId 1..1II
.... @nullFlavor 0..1csBinding: NullFlavor (required)
.... @assigningAuthorityName 0..1st
.... @displayable 0..1bl
.... @root 1..1oid, uuid, ruidRequired Pattern: 2.16.840.1.113883.10.20.22.4.304
.... @extension 1..1stRequired Pattern: 2022-06-01
... id 0..*II
... code 1..1CDPrimary DI Number Code from NCIt
Binding: ObservationType (extensible)
.... @nullFlavor 0..1csBinding: NullFlavor (required)
.... @code 1..1csRequired Pattern: C101722
.... @codeSystem 1..1oid, uuid, ruidRequired Pattern: 2.16.840.1.113883.3.26.1.1
.... @codeSystemName 0..1stRequired Pattern: NCI Thesaurus
.... @codeSystemVersion 0..1st
.... @displayName 0..1stRequired Pattern: Primary DI Number
.... @sdtcValueSet 0..1oidXML Namespace: urn:hl7-org:sdtc
XML: valueSet (urn:hl7-org:sdtc)
.... @sdtcValueSetVersion 0..1stXML Namespace: urn:hl7-org:sdtc
XML: valueSetVersion (urn:hl7-org:sdtc)
.... originalText 0..1ED
.... qualifier 0..*CR
.... translation 0..*CD
... derivationExpr 0..1ST
... text 0..1ED
... statusCode 0..1CSBinding: ActStatus (required)
... effectiveTime 0..1IVL_TS
... priorityCode 0..1CEBinding: ActPriority (extensible)
... repeatNumber 0..1IVL_INT
... languageCode 0..1CSBinding: HumanLanguage (required)
... value 1..1IIThis value is assigned by the Manufacturer by using an FDA-accredited UDI-issuing agency
.... @nullFlavor 0..1csBinding: NullFlavor (required)
.... @assigningAuthorityName 0..1st
.... @displayable 1..1bl
.... @root 1..1oid, uuid, ruid
.... @extension 0..1st
... interpretationCode 0..*CEBinding: ObservationInterpretation (required)
... methodCode 0..*CEBinding: ObservationMethod (extensible)
... targetSiteCode 0..*CD
... subject 0..1Subject
... specimen 0..*Specimen
... performer 0..*Performer2
... author 0..*Author
... informant 0..*Informant
... participant 0..*Participant2
... entryRelationship 0..*EntryRelationship
... reference 0..*Reference
... precondition 0..*Precondition
... referenceRange 0..*InfrastructureRoot
.... @nullFlavor 0..1csBinding: NullFlavor (required)
.... realmCode 0..*CS
.... typeId 0..1II
.... templateId 0..*II
.... @typeCode 0..1csBinding: ActRelationshipPertains (required)
Fixed Value: REFV
.... observationRange 1..1ObservationRange

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / Code
Observation.classCoderequiredActClassObservation
Observation.templateId.nullFlavorrequiredNullFlavor
Observation.codeextensibleObservationType
Observation.code.nullFlavorrequiredNullFlavor
Observation.statusCoderequiredActStatus
Observation.priorityCodeextensibleActPriority
Observation.languageCoderequiredHumanLanguage (a valid code from http://terminology.hl7.org/CodeSystem/ietf3066)
Observation.value.nullFlavorrequiredNullFlavor
Observation.interpretationCoderequiredObservationInterpretation
Observation.methodCodeextensibleObservationMethod
Observation.referenceRange.nullFlavorrequiredNullFlavor
Observation.referenceRange.typeCoderequiredFixed Value: REFV

Constraints

IdGradePath(s)DetailsRequirements
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())

This structure is derived from CDAR2.Observation

Summary

Mandatory: 8 elements

Differential View

This structure is derived from CDAR2.Observation

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation 1..1CDAR2.ObservationXML Namespace: urn:hl7-org:v3
Elements defined in Ancestors: @classCode, @moodCode, @negationInd, realmCode, typeId, templateId, id, code, derivationExpr, text, statusCode, effectiveTime, priorityCode, repeatNumber, languageCode, value, interpretationCode, methodCode, targetSiteCode, subject, specimen, performer, author, informant, participant, entryRelationship, reference, precondition, referenceRange
Base for all types and resources
... templateId 1..1II
.... root 1..1oid, uuid, ruidRequired Pattern: 2.16.840.1.113883.10.20.22.4.304
.... extension 1..1stRequired Pattern: 2022-06-01
... code 1..1CDPrimary DI Number Code from NCIt
.... code 1..1csRequired Pattern: C101722
.... codeSystem 1..1oid, uuid, ruidRequired Pattern: 2.16.840.1.113883.3.26.1.1
.... codeSystemName 0..1stRequired Pattern: NCI Thesaurus
.... displayName 0..1stRequired Pattern: Primary DI Number
... value 1..1IIThis value is assigned by the Manufacturer by using an FDA-accredited UDI-issuing agency
.... displayable 1..1bl
.... root 1..1oid, uuid, ruid
.... extension 0..1st

doco Documentation for this format

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation 1..1CDAR2.ObservationXML Namespace: urn:hl7-org:v3
Elements defined in Ancestors: @classCode, @moodCode, @negationInd, realmCode, typeId, templateId, id, code, derivationExpr, text, statusCode, effectiveTime, priorityCode, repeatNumber, languageCode, value, interpretationCode, methodCode, targetSiteCode, subject, specimen, performer, author, informant, participant, entryRelationship, reference, precondition, referenceRange
Base for all types and resources
... @classCode 1..1csBinding: ActClassObservation (required)
... @moodCode 1..1cs
... templateId 1..1II
.... @root 1..1oid, uuid, ruidRequired Pattern: 2.16.840.1.113883.10.20.22.4.304
.... @extension 1..1stRequired Pattern: 2022-06-01
.... @code 1..1csRequired Pattern: C101722
.... @codeSystem 1..1oid, uuid, ruidRequired Pattern: 2.16.840.1.113883.3.26.1.1
.... @codeSystemName 0..1stRequired Pattern: NCI Thesaurus
.... @displayName 0..1stRequired Pattern: Primary DI Number
... value 1..1IIThis value is assigned by the Manufacturer by using an FDA-accredited UDI-issuing agency
.... @displayable 1..1bl
.... @root 1..1oid, uuid, ruid
.... @extension 0..1st

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet
Observation.classCoderequiredActClassObservation
Observation.codeextensibleObservationType

Constraints

IdGradePath(s)DetailsRequirements
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation 1..1CDAR2.ObservationXML Namespace: urn:hl7-org:v3
Elements defined in Ancestors: @classCode, @moodCode, @negationInd, realmCode, typeId, templateId, id, code, derivationExpr, text, statusCode, effectiveTime, priorityCode, repeatNumber, languageCode, value, interpretationCode, methodCode, targetSiteCode, subject, specimen, performer, author, informant, participant, entryRelationship, reference, precondition, referenceRange
Base for all types and resources
... @classCode 1..1csBinding: ActClassObservation (required)
... @moodCode 1..1cs
... @negationInd 0..1bl
... realmCode 0..*CS
... typeId 0..1II
... templateId 1..1II
.... @nullFlavor 0..1csBinding: NullFlavor (required)
.... @assigningAuthorityName 0..1st
.... @displayable 0..1bl
.... @root 1..1oid, uuid, ruidRequired Pattern: 2.16.840.1.113883.10.20.22.4.304
.... @extension 1..1stRequired Pattern: 2022-06-01
... id 0..*II
... code 1..1CDPrimary DI Number Code from NCIt
Binding: ObservationType (extensible)
.... @nullFlavor 0..1csBinding: NullFlavor (required)
.... @code 1..1csRequired Pattern: C101722
.... @codeSystem 1..1oid, uuid, ruidRequired Pattern: 2.16.840.1.113883.3.26.1.1
.... @codeSystemName 0..1stRequired Pattern: NCI Thesaurus
.... @codeSystemVersion 0..1st
.... @displayName 0..1stRequired Pattern: Primary DI Number
.... @sdtcValueSet 0..1oidXML Namespace: urn:hl7-org:sdtc
XML: valueSet (urn:hl7-org:sdtc)
.... @sdtcValueSetVersion 0..1stXML Namespace: urn:hl7-org:sdtc
XML: valueSetVersion (urn:hl7-org:sdtc)
.... originalText 0..1ED
.... qualifier 0..*CR
.... translation 0..*CD
... derivationExpr 0..1ST
... text 0..1ED
... statusCode 0..1CSBinding: ActStatus (required)
... effectiveTime 0..1IVL_TS
... priorityCode 0..1CEBinding: ActPriority (extensible)
... repeatNumber 0..1IVL_INT
... languageCode 0..1CSBinding: HumanLanguage (required)
... value 1..1IIThis value is assigned by the Manufacturer by using an FDA-accredited UDI-issuing agency
.... @nullFlavor 0..1csBinding: NullFlavor (required)
.... @assigningAuthorityName 0..1st
.... @displayable 1..1bl
.... @root 1..1oid, uuid, ruid
.... @extension 0..1st
... interpretationCode 0..*CEBinding: ObservationInterpretation (required)
... methodCode 0..*CEBinding: ObservationMethod (extensible)
... targetSiteCode 0..*CD
... subject 0..1Subject
... specimen 0..*Specimen
... performer 0..*Performer2
... author 0..*Author
... informant 0..*Informant
... participant 0..*Participant2
... entryRelationship 0..*EntryRelationship
... reference 0..*Reference
... precondition 0..*Precondition
... referenceRange 0..*InfrastructureRoot
.... @nullFlavor 0..1csBinding: NullFlavor (required)
.... realmCode 0..*CS
.... typeId 0..1II
.... templateId 0..*II
.... @typeCode 0..1csBinding: ActRelationshipPertains (required)
Fixed Value: REFV
.... observationRange 1..1ObservationRange

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / Code
Observation.classCoderequiredActClassObservation
Observation.templateId.nullFlavorrequiredNullFlavor
Observation.codeextensibleObservationType
Observation.code.nullFlavorrequiredNullFlavor
Observation.statusCoderequiredActStatus
Observation.priorityCodeextensibleActPriority
Observation.languageCoderequiredHumanLanguage (a valid code from http://terminology.hl7.org/CodeSystem/ietf3066)
Observation.value.nullFlavorrequiredNullFlavor
Observation.interpretationCoderequiredObservationInterpretation
Observation.methodCodeextensibleObservationMethod
Observation.referenceRange.nullFlavorrequiredNullFlavor
Observation.referenceRange.typeCoderequiredFixed Value: REFV

Constraints

IdGradePath(s)DetailsRequirements
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())

This structure is derived from CDAR2.Observation

Summary

Mandatory: 8 elements

 

Other representations of profile: CSV, Excel