UDI Compliance: What is a Unit of Use DI? When is it required?

The Unit of Use Device Identifier (DI) is a requirement of the Global UDI Database (GUDID).  A Unit of Use DI refers to a product within a package that is not marked with its own Unique Device Identifier (UDI).  For example, an individual bandage in a box of 10 will need a Unit of Use Identifier.  When you submit data for the box of 10 bandages to the GUDID, you will be required to submit a virtual identifier called the Unit of Use DI for each bandage.  Because the identifier is virtual, you are not required to physically place a Unit of Use DI on each bandage within a package.  The Unit of Use DI is a method to discuss, describe and document a single bandage in the GUDID.


USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet UDI regulations. Our team of UDI experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM’s assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to the GUDID.