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Unique Device Identification System

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The Unique Device Identification System, commonly referred to as UDI, is a Food and Drug Administration (FDA) rule that requires medical device labelers to mark medical packages and devices with a unique barcode. These labels aid supply chain and healthcare professionals in accurately identifying of medical devices during transit and use.

UDI labels must be applied to medical devices or stand-alone software that are deemed life-sustaining, life-supporting, or implantable. A UDI label must be applied permanently to the body of the device if it is designed to be used more than once.

  1. Device Identifier
  2. Lot number
  3. Serial Number
  4. Manufacture Date
  5. Expiration Date
UDIGTNHIBCCICCBBA
UDI:Device Identifier (UDI-DI)GTN: Global Trade Item NumberHIBCC: HIBC-LIC (Labeler Identification Code)ICCBBA: ISBT-28 PPIC (Processor Product Identification Code)
Production Identifier (UDI-PI)Application Identifier (AI) becomes a part of PIFlag Characters  HIBC UDI format for PIFor PI (Product Identifier) one or more elements of ISBT 28 Data Structure can be used