GS1, Health Industry Business Communications Council (HIBCC), and International Council for Commonality in Blood Banking Automation (ICCBBA) have each been approved by IMDRF (International Medical Device Regulator Forum), the United States Food and Drug Administration (FDA) and the European Commission to create the Unique Device Identification (UDI) standard to mark and identify healthcare devices.
These UDI identifiers will be stored in a Global Unique Device Identification Database (GUDID) helping the health industry identify devices and electronic health records across multiple systems and sources. The UDI barcode must appear as a barcode using either
Code 128 or Data Matrix and include the human readable format as well. Each unique UDI barcode must appear on all levels of packaging, whether it is base, single or multi-packaging and submitted to the FDA GUDID.
Each agency has their own format for the UDI, below are links to an overview of each FDA approved UDI rule with technical formats of the Device Identifier (DI) and the Production Identifier (PI).
- GS1 UDI
- HIBCC UDI – Health Industry Business Communications Council
- ICCBBA UDI – International Council for Commonality in Blood Banking Automation