| CommonProduct UML Documentation |
Summary:AttributesProperties | Detail:Attributes |
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 |
"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 |
"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 |
"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 |
"A coded entry to indicate how the data was entered." - HL7 FHIR, Device.udi.entryType |
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 |
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 |
String | name |
"Name of device as used in labeling or catalog." - HL7 FHIR, Device.udi.name |
Properties:
Alias | |
Classifier Behavior | |
Is Abstract | false |
Is Active | false |
Is Leaf | false |
Keywords | |
Name | UniqueDeviceIdentifier |
Name Expression | |
Namespace | CommonProduct |
Owned Template Signature | |
Owner | CommonProduct |
Owning Template Parameter | |
Package | CommonProduct |
Qualified Name | FHIM::CommonProduct::UniqueDeviceIdentifier |
Representation | |
Stereotype | |
Template Parameter | |
Visibility | Public |
Attribute Details |
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
Aggregation | None |
Alias | |
Association | |
Association End | |
Class | UniqueDeviceIdentifier |
Datatype | |
Default | |
Default Value | |
Is Composite | false |
Is Derived | false |
Is Derived Union | false |
Is Leaf | false |
Is Ordered | false |
Is Read Only | false |
Is Static | false |
Is Unique | true |
Keywords | |
Lower | 0 |
Lower Value | (0) |
Multiplicity | 0..1 |
Name | carrierAIDC |
Name Expression | |
Namespace | UniqueDeviceIdentifier |
Opposite | |
Owner | UniqueDeviceIdentifier |
Owning Association | |
Owning Template Parameter | |
Qualified Name | FHIM::CommonProduct::UniqueDeviceIdentifier::carrierAIDC |
Stereotype | |
Template Parameter | |
Type | String |
Upper | 1 |
Upper Value | (1) |
Visibility | Public |
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
Aggregation | None |
Alias | |
Association | |
Association End | |
Class | UniqueDeviceIdentifier |
Datatype | |
Default | |
Default Value | |
Is Composite | false |
Is Derived | false |
Is Derived Union | false |
Is Leaf | false |
Is Ordered | false |
Is Read Only | false |
Is Static | false |
Is Unique | true |
Keywords | |
Lower | 0 |
Lower Value | (0) |
Multiplicity | 0..1 |
Name | carrierHRF |
Name Expression | |
Namespace | UniqueDeviceIdentifier |
Opposite | |
Owner | UniqueDeviceIdentifier |
Owning Association | |
Owning Template Parameter | |
Qualified Name | FHIM::CommonProduct::UniqueDeviceIdentifier::carrierHRF |
Stereotype | |
Template Parameter | |
Type | String |
Upper | 1 |
Upper Value | (1) |
Visibility | Public |
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
Aggregation | None |
Alias | |
Association | |
Association End | |
Class | UniqueDeviceIdentifier |
Datatype | |
Default | |
Default Value | |
Is Composite | false |
Is Derived | false |
Is Derived Union | false |
Is Leaf | false |
Is Ordered | false |
Is Read Only | false |
Is Static | false |
Is Unique | true |
Keywords | |
Lower | 0 |
Lower Value | (0) |
Multiplicity | 0..1 |
Name | deviceIdentifier |
Name Expression | |
Namespace | UniqueDeviceIdentifier |
Opposite | |
Owner | UniqueDeviceIdentifier |
Owning Association | |
Owning Template Parameter | |
Qualified Name | FHIM::CommonProduct::UniqueDeviceIdentifier::deviceIdentifier |
Stereotype | |
Template Parameter | |
Type | String |
Upper | 1 |
Upper Value | (1) |
Visibility | Public |
Public «CS» Code entryType
"A coded entry to indicate how the data was entered." - HL7 FHIR, Device.udi.entryType
Aggregation | None |
Alias | |
Association | |
Association End | |
Class | UniqueDeviceIdentifier |
Datatype | |
Default | |
Default Value | |
Is Composite | false |
Is Derived | false |
Is Derived Union | false |
Is Leaf | false |
Is Ordered | false |
Is Read Only | false |
Is Static | false |
Is Unique | true |
Keywords | |
Lower | 0 |
Lower Value | (0) |
Multiplicity | 0..1 |
Name | entryType |
Name Expression | |
Namespace | UniqueDeviceIdentifier |
Opposite | |
Owner | UniqueDeviceIdentifier |
Owning Association | |
Owning Template Parameter | |
Qualified Name | FHIM::CommonProduct::UniqueDeviceIdentifier::entryType |
Stereotype | |
Template Parameter | |
Type | «CS» Code |
Upper | 1 |
Upper Value | (1) |
Visibility | Public |
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
Aggregation | None |
Alias | |
Association | |
Association End | |
Class | UniqueDeviceIdentifier |
Datatype | |
Default | |
Default Value | |
Is Composite | false |
Is Derived | false |
Is Derived Union | false |
Is Leaf | false |
Is Ordered | false |
Is Read Only | false |
Is Static | false |
Is Unique | true |
Keywords | |
Lower | 0 |
Lower Value | (0) |
Multiplicity | 0..1 |
Name | issuer |
Name Expression | |
Namespace | UniqueDeviceIdentifier |
Opposite | |
Owner | UniqueDeviceIdentifier |
Owning Association | |
Owning Template Parameter | |
Qualified Name | FHIM::CommonProduct::UniqueDeviceIdentifier::issuer |
Stereotype | |
Template Parameter | |
Type | String |
Upper | 1 |
Upper Value | (1) |
Visibility | Public |
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
Aggregation | None |
Alias | |
Association | |
Association End | |
Class | UniqueDeviceIdentifier |
Datatype | |
Default | |
Default Value | |
Is Composite | false |
Is Derived | false |
Is Derived Union | false |
Is Leaf | false |
Is Ordered | false |
Is Read Only | false |
Is Static | false |
Is Unique | true |
Keywords | |
Lower | 0 |
Lower Value | (0) |
Multiplicity | 0..1 |
Name | jurisdiction |
Name Expression | |
Namespace | UniqueDeviceIdentifier |
Opposite | |
Owner | UniqueDeviceIdentifier |
Owning Association | |
Owning Template Parameter | |
Qualified Name | FHIM::CommonProduct::UniqueDeviceIdentifier::jurisdiction |
Stereotype | |
Template Parameter | |
Type | String |
Upper | 1 |
Upper Value | (1) |
Visibility | Public |
Public String name
"Name of device as used in labeling or catalog." - HL7 FHIR, Device.udi.name
Aggregation | None |
Alias | |
Association | |
Association End | |
Class | UniqueDeviceIdentifier |
Datatype | |
Default | |
Default Value | |
Is Composite | false |
Is Derived | false |
Is Derived Union | false |
Is Leaf | false |
Is Ordered | false |
Is Read Only | false |
Is Static | false |
Is Unique | true |
Keywords | |
Lower | 0 |
Lower Value | (0) |
Multiplicity | 0..1 |
Name | name |
Name Expression | |
Namespace | UniqueDeviceIdentifier |
Opposite | |
Owner | UniqueDeviceIdentifier |
Owning Association | |
Owning Template Parameter | |
Qualified Name | FHIM::CommonProduct::UniqueDeviceIdentifier::name |
Stereotype | |
Template Parameter | |
Type | String |
Upper | 1 |
Upper Value | (1) |
Visibility | Public |
| CommonProduct UML Documentation |
Summary:AttributesProperties | Detail:Attributes |