description: 'This template is intended to be used in addition to the Product Instance template 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.\n\nThe 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'
package_name: hl7.cda.us.ccda
derivation: constraint
name: DeviceIdentifierObservation
type: http://hl7.org/cda/stds/core/StructureDefinition/Observation
elements:
  templateId:
    index: 0
    slicing:
      rules: open
      discriminator:
      - {path: root, type: value}
      - {path: extension, type: value}
      min: 1
      slices:
        device-id-obs:
          match: {root: 2.16.840.1.113883.10.20.22.4.304, extension: '2022-06-01'}
          schema:
            _required: true
            index: 1
            elements:
              root:
                pattern: {type: String, value: 2.16.840.1.113883.10.20.22.4.304}
                index: 2
              extension:
                pattern: {type: String, value: '2022-06-01'}
                index: 3
            required: [root, extension]
            extensions: {}
  code:
    short: Primary DI Number Code from NCIt
    index: 4
    elements:
      code:
        pattern: {type: Code, value: C101722}
        index: 5
      codeSystem:
        pattern: {type: String, value: 2.16.840.1.113883.3.26.1.1}
        index: 6
      codeSystemName: {short: MAY be set to 'NCI Thesaurus', index: 7}
      displayName: {short: MAY be set to 'Primary DI Number', index: 8}
    required: [codeSystem, code]
  text:
    short: SHOULD reference the portion of section narrative text corresponding to this entry
    index: 9
    elements:
      reference:
        constraint:
          value-starts-octothorpe: {human: 'If reference/@value is present, it SHALL begin with a ''#'' and SHALL point to its corresponding narrative', source: 'http://hl7.org/cda/us/ccda/StructureDefinition/DeviceIdentifierObservation', severity: error, expression: value.exists() implies value.startsWith('#')}
        index: 10
  value:
    type: http://hl7.org/cda/stds/core/StructureDefinition/II
    short: This value is assigned by the Manufacturer by using an FDA-accredited UDI-issuing agency
    constraint:
      should-extension: {human: SHOULD contain extension, source: 'http://hl7.org/cda/us/ccda/StructureDefinition/DeviceIdentifierObservation', severity: warning, expression: extension.exists()}
    index: 11
    elements:
      displayable:
        pattern: {type: Boolean, value: true}
        index: 12
      root: {index: 13}
      extension: {index: 14}
    required: [root, displayable]
    extensions: {}
package_version: 3.0.0
class: logical
kind: logical
url: http://hl7.org/cda/us/ccda/StructureDefinition/DeviceIdentifierObservation
base: http://hl7.org/cda/stds/core/StructureDefinition/Observation
version: 3.0.0
required: [value, templateId]