Can You Use ISBT 128 for Non-Human Cells, Tissues, and Cellular Tissue-Base Product (HTC/P) Devices?

Generally speaking, you can’t use ISBT 128 for non-Human Cells, Tissues, and Cellular Tissue-Base Product (HTC/P) devices. There is one exception. You may use ISBT 128 for empty blood bags. We suggest people look at the Global Unique Device Identifier Database (GUDID) and Global Standards One (GS1) for anything that is not an HTC/P.

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.