Product packaging that is UDI-compliant, makes it easy to track a product from the manufacturing site to its use at a patient’s bedside. Barcodes in linear and 2D formats allow for easy scanning at most packaging levels.

Current UDI Compliance

The image illustrates ICU Medical’s current UDI compliance.

Packaging Levels

Each/Primary/Point of Use

The packaging level closest to the product.


The packaging level containing one or more primary levels of the same product.


The shipping level of packaging.

UDI Compliant Labels

ICU Medical meets global UDI Compliance standards on our labels in 3 ways:

  • Standardized date format in YYYY-MM-DD
  • Device identification that includes:
    • GTIN – a fixed, product identifier
    • Variable production identifiers
  • Plain text and barcode formats


Global Trade Identification Numbers (GTINs) are a crucial part of the UDI system. These unique 14-digit numbers are required on device labeling and packaging (except in special cases of exemption). The GTIN appears in the first portion of the Device Identifier (DI) (for example: (01) 12345678912345).