CommonProduct / UniqueDeviceIdentifier — UniqueDeviceIdentifier
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FHIR: 0 resource(s),
0 attribute(s) mapped
Qualified: CommonProduct::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 / الخصائص
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