ResMed will introduce UDI labeling as a rolling change across its products intended for sale in the US, over the course of several years. We have adopted a 2D barcode, utilizing the GS1 Standards to comply with UDI requirements from the FDA. The 2D barcode provides greater flexibility than the 1D barcode currently used for our serial and catalog numbers.
ResMed uses a Global Trade Identification Number (GTIN) to create the 1D barcode found on ResMed packaging.
More than one GTIN number may exist for each catalog number. When a product undergoes a significant change, ResMed creates an additional GTIN for the corresponding catalog number.
ResMed provides lookup tables* upon request for your inventory management systems. Refer to these tables to map catalog numbers to corresponding GTIN numbers.
If you would like to obtain a current look up table, please email CustomerCare@resmed.com or call 1-800-424-0737.
The 2D barcode provides greater flexibility than the 1D barcode used for our serial and catalog numbers. 2D barcodes require an image scanner that can read text both vertically and horizontally, which allows them to store more information. 1D barcode scanners can only read text horizontally.
For more information about Unique Device Identification (UDI) and 2D barcodes, please visit resmed.com/udi.
Note: 2D barcode scanners can scan both 2D and 1D barcodes; however, 1D barcode scanners cannot read 2D barcodes.
What are the GS1 Standards?
The GS1 Standards include the use of Application Identifiers (AIs), which are multi-digit prefixes that identify the specific type of data. For example, when scanning a serial number/barcode, a “21” will appear before the actual serial number. This notifies any GS1 compliant scanner or system that the numbers after the "21" are a serial number and not a random set of numbers.
The GS1 Standards are used globally by manufacturing companies to ensure data captured from GS1 barcodes are unambiguous, and can electronically communicate this data to inventory management systems.
To learn more about GS1 in the healthcare industry, or about 2D barcodes and AIs, visit the GS1 website.
Most barcode scanners will automatically decode GS1 compliant barcodes. If you are uncertain if your barcode scanner is GS1 capable, please contact your barcode scanner supplier.