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Device Identifier (DI) & Production Identifier (PI)

Device Identifier (DI)​

The Device Identifier (DI) is the mandatory, fixed portion of the UDI that identifies the specific version or model of a device. A unique DI must be obtained for each:

  • Device labeller (not just manufacturer)
  • Version or model of the device
  • Level of packaging (individual unit, case, pallet)

The DI for the base package (individual unit) is called the Primary DI — this is the DI submitted to the GUDID database.

Production Identifier (PI)​

The Production Identifier (PI) is the conditional, variable portion of the UDI. It must include one or more of the following if they appear on the label:

PI elementRequired when
Lot or batch numberDevice is assigned a lot/batch number
Serial numberDevice is assigned a serial number
Manufacturing dateDate appears on the label
Expiration/use-by dateDate appears on the label
Distinct identification code (for HCT/Ps)For human cells, tissues, and cellular/tissue-based products

Devices exempt from PI​

Some devices are exempt from displaying the PI on the label:

  • Class I devices exempt from UDI labelling requirements
  • Small devices where space limitations make the full UDI impractical (alternative compliance methods apply)

Official resources​