For medical device companies only: GS1 US Data Hub enables you to create the Primary Device DI for your medical devices.
View the UDI Creation User Guide (PDF) for instructions.
In 2022, GS1 US Data Hub added an optional “Unit of Use” packaging level. The Unit of Use DI is defined as an identifier assigned to an individual medical device when the Primary DI has a "count of devices" greater than 1.
The Unit of Use DI is assigned to the single device below the lowest saleable unit marked with a DI. This allows for unique identification of the actual device used in patient care.
This option conserves the GS1 Company Prefix GTIN capacity, and also enables you to associate the “Unit of Use DI” as part of the Primary Device DI Product Hierarchy:
To get started, click the Administration link on the main GS1 US Data Hub page.
Under Product, General Settings, click the Manage link. Check the box for Enable Unit of Use Packaging Level. Then click "Save."
Now you can click Product and create the Primary Device DI in GS1 US Data Hub. You can then create the Unit of Use item (select Unit of Use from the Packaging Level drop-down), and associate it with the Primary DI.
Creating a UDI Module:
Creating a UDI Guide:
