Product Labeling and Packaging Information | 合法醫療器材資訊網

Standardizedlabelingmaintainscompliancewithchangingglobalregulatoryrequirements.Learnabouttheappearanceofourproductlabeling.

To meet customer and regulatory requirements, we began adding two-dimensional (2D) GS1 Data Matrix bar codes to product packages in 2015. The GS1 bar codes comply with unique device identifier (UDI) requirements mandated by the FDA to adequately identify medical devices throughout their distribution and use.

To include all the necessary information on the bar code label without increasing packaging, some of the linear bar codes have been replaced by 2D GS1 codes. See a list of the impacted products ›[1]

Note: Reading 2D bar codes may require upgrading your facilitys scanning equipment in the receiving area. Please communicate this change to all appropriate individuals.

Examples: 

Example of a 2D GS1 Data Matrix bar code

Example of a linear HIBC bar code

No action is required in the l...