Customers should be ready to accept NEW UPC barcodes by December 1, 2016
The FDA is requiring that all Class II medical device labels include Unique Device Identifiers (UDI). In conjunction with the new UDI assignments, DJO is changing the UPC barcodes to align with the GTIN (the device identifier included in the UDI), effective September 24, 2016. The change ensures uniformity in label codes to adequately identify medical devices through their distribution and use. The label for most products/devices will include a UDI in human and machine-readable form, i.e. linear barcode or 2D matrix format.
Products impacted by this change include: Compression Hosiery; TheraTherm hot therapy; and Muscle Stim within the Brands: Aircast, Bell-Horn, Chattanooga, Compex, DonJoy, & Shape-to-Fit.
As part of this code change, it is imperative that:
- Customers have systems/resources in place to support this change as of December 1, 2016
- Customers change over their systems for receipt of new UPC bar code transactions as close to the December 1st date as possible*
* Note: DJO Global will continue to ship inventory made prior to September 24th from the Distribution Centers with the former UPC until December 1, 2016. After December 1st all product will be labeled with new UPC therefore, during this transition period some product may have both new and old UPC bar code labels to ensure transactions are not disrupted during the transition period. We urge our customers to update their systems as close to the December 1st date as possible.
Answers to questions you may have regarding these changes may be found in the documents below, or by contacting global.regulatory@djoglobal.com