CommonProduct
Class UniqueDeviceIdentifier

This class records information that can identify and track devices through distribution and use. This information is or will be required by multiple jurisdictions; currently the United States Food and Drug Administration (FDA) is the first jurisdiction to issue regulations on Unique Device Identifiers. Other countries will likely use the same identifiers or will require some variant, which will be included in this class in the future. See: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification
"In 2013, the FDA released a final rule establishing a unique device identification system designed to adequately identify devices through distribution and use. The final rule requires device labelers to include a unique device identifier (UDI) on device labels and packages.... Each UDI must be provided in a plain-text version and in a form that uses automatic identification and data capture (AIDC) technology. The UDI will also be required to be directly marked on a device that is intended for more than one use, and intended to be reprocessed before each use.
A UDI is a unique numeric or alphanumeric code that consists of two parts: a) a device identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device, and b) a production identifier (PI), a conditional, variable portion of a UDI that identifies such things as: i) the lot or batch number within which a device was manufactured; ii) the serial number of a specific device; iii) expiration date of a specific device; iv) the date a specific device was manufactured; v) and others." - from FDA "UDI Basics" website
"Unique device identifier (UDI) assigned to device label or package." - HL7 FHIR, Device.udi

Attributes
String carrierAIDC carrierAIDC

"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." - HL7 FHIR, Device.udi.carrierAIDC

String carrierHRF carrierHRF

"The full UDI carrier as the human readable form (HRF) representation of the barcode string as printed on the packaging of the device." - HL7 FHIR, Device.udi.carrierHRF

String deviceIdentifier deviceIdentifier

"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." - HL7 FHIR, Device.udi.deviceIdentifier

«CS» Code entryType entryType

"A coded entry to indicate how the data was entered." - HL7 FHIR, Device.udi.entryType

String issuer issuer

"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." - HL7 FHIR, Device.udi.issuer

String jurisdiction jurisdiction

"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." - HL7 FHIR, Device.udi.jurisdiction

String name name

"Name of device as used in labeling or catalog." - HL7 FHIR, Device.udi.name


Properties:

Alias
Classifier Behavior
Is Abstractfalse
Is Activefalse
Is Leaffalse
Keywords
NameUniqueDeviceIdentifier
Name Expression
NamespaceCommonProduct
Owned Template Signature
OwnerCommonProduct
Owning Template Parameter
PackageCommonProduct
Qualified NameFHIM::CommonProduct::UniqueDeviceIdentifier
Representation
Stereotype
Template Parameter
VisibilityPublic

Attribute Details

 carrierAIDC
Public String carrierAIDC

"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." - HL7 FHIR, Device.udi.carrierAIDC

Constraints:
Properties:

AggregationNone
Alias
Association
Association End
ClassUniqueDeviceIdentifier
Datatype
Default
Default Value
Is Compositefalse
Is Derivedfalse
Is Derived Unionfalse
Is Leaffalse
Is Orderedfalse
Is Read Onlyfalse
Is Staticfalse
Is Uniquetrue
Keywords
Lower0
Lower Value(0)
Multiplicity0..1
NamecarrierAIDC
Name Expression
NamespaceUniqueDeviceIdentifier
Opposite
OwnerUniqueDeviceIdentifier
Owning Association
Owning Template Parameter
Qualified NameFHIM::CommonProduct::UniqueDeviceIdentifier::carrierAIDC
Stereotype
Template Parameter
TypeString
Upper1
Upper Value(1)
VisibilityPublic


 carrierHRF
Public String carrierHRF

"The full UDI carrier as the human readable form (HRF) representation of the barcode string as printed on the packaging of the device." - HL7 FHIR, Device.udi.carrierHRF

Constraints:
Properties:

AggregationNone
Alias
Association
Association End
ClassUniqueDeviceIdentifier
Datatype
Default
Default Value
Is Compositefalse
Is Derivedfalse
Is Derived Unionfalse
Is Leaffalse
Is Orderedfalse
Is Read Onlyfalse
Is Staticfalse
Is Uniquetrue
Keywords
Lower0
Lower Value(0)
Multiplicity0..1
NamecarrierHRF
Name Expression
NamespaceUniqueDeviceIdentifier
Opposite
OwnerUniqueDeviceIdentifier
Owning Association
Owning Template Parameter
Qualified NameFHIM::CommonProduct::UniqueDeviceIdentifier::carrierHRF
Stereotype
Template Parameter
TypeString
Upper1
Upper Value(1)
VisibilityPublic


 deviceIdentifier
Public String deviceIdentifier

"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." - HL7 FHIR, Device.udi.deviceIdentifier

Constraints:
Properties:

AggregationNone
Alias
Association
Association End
ClassUniqueDeviceIdentifier
Datatype
Default
Default Value
Is Compositefalse
Is Derivedfalse
Is Derived Unionfalse
Is Leaffalse
Is Orderedfalse
Is Read Onlyfalse
Is Staticfalse
Is Uniquetrue
Keywords
Lower0
Lower Value(0)
Multiplicity0..1
NamedeviceIdentifier
Name Expression
NamespaceUniqueDeviceIdentifier
Opposite
OwnerUniqueDeviceIdentifier
Owning Association
Owning Template Parameter
Qualified NameFHIM::CommonProduct::UniqueDeviceIdentifier::deviceIdentifier
Stereotype
Template Parameter
TypeString
Upper1
Upper Value(1)
VisibilityPublic


 entryType
Public «CS» Code entryType

"A coded entry to indicate how the data was entered." - HL7 FHIR, Device.udi.entryType

Constraints:
Properties:

AggregationNone
Alias
Association
Association End
ClassUniqueDeviceIdentifier
Datatype
Default
Default Value
Is Compositefalse
Is Derivedfalse
Is Derived Unionfalse
Is Leaffalse
Is Orderedfalse
Is Read Onlyfalse
Is Staticfalse
Is Uniquetrue
Keywords
Lower0
Lower Value(0)
Multiplicity0..1
NameentryType
Name Expression
NamespaceUniqueDeviceIdentifier
Opposite
OwnerUniqueDeviceIdentifier
Owning Association
Owning Template Parameter
Qualified NameFHIM::CommonProduct::UniqueDeviceIdentifier::entryType
Stereotype
Template Parameter
Type«CS» Code
Upper1
Upper Value(1)
VisibilityPublic


 issuer
Public String issuer

"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." - HL7 FHIR, Device.udi.issuer

Constraints:
Properties:

AggregationNone
Alias
Association
Association End
ClassUniqueDeviceIdentifier
Datatype
Default
Default Value
Is Compositefalse
Is Derivedfalse
Is Derived Unionfalse
Is Leaffalse
Is Orderedfalse
Is Read Onlyfalse
Is Staticfalse
Is Uniquetrue
Keywords
Lower0
Lower Value(0)
Multiplicity0..1
Nameissuer
Name Expression
NamespaceUniqueDeviceIdentifier
Opposite
OwnerUniqueDeviceIdentifier
Owning Association
Owning Template Parameter
Qualified NameFHIM::CommonProduct::UniqueDeviceIdentifier::issuer
Stereotype
Template Parameter
TypeString
Upper1
Upper Value(1)
VisibilityPublic


 jurisdiction
Public String jurisdiction

"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." - HL7 FHIR, Device.udi.jurisdiction

Constraints:
Properties:

AggregationNone
Alias
Association
Association End
ClassUniqueDeviceIdentifier
Datatype
Default
Default Value
Is Compositefalse
Is Derivedfalse
Is Derived Unionfalse
Is Leaffalse
Is Orderedfalse
Is Read Onlyfalse
Is Staticfalse
Is Uniquetrue
Keywords
Lower0
Lower Value(0)
Multiplicity0..1
Namejurisdiction
Name Expression
NamespaceUniqueDeviceIdentifier
Opposite
OwnerUniqueDeviceIdentifier
Owning Association
Owning Template Parameter
Qualified NameFHIM::CommonProduct::UniqueDeviceIdentifier::jurisdiction
Stereotype
Template Parameter
TypeString
Upper1
Upper Value(1)
VisibilityPublic


 name
Public String name

"Name of device as used in labeling or catalog." - HL7 FHIR, Device.udi.name

Constraints:
Properties:

AggregationNone
Alias
Association
Association End
ClassUniqueDeviceIdentifier
Datatype
Default
Default Value
Is Compositefalse
Is Derivedfalse
Is Derived Unionfalse
Is Leaffalse
Is Orderedfalse
Is Read Onlyfalse
Is Staticfalse
Is Uniquetrue
Keywords
Lower0
Lower Value(0)
Multiplicity0..1
Namename
Name Expression
NamespaceUniqueDeviceIdentifier
Opposite
OwnerUniqueDeviceIdentifier
Owning Association
Owning Template Parameter
Qualified NameFHIM::CommonProduct::UniqueDeviceIdentifier::name
Stereotype
Template Parameter
TypeString
Upper1
Upper Value(1)
VisibilityPublic