Puritan Updates Labels to Comply with Unique Device Identification (UDI) System

In order to comply with the FDA’s new, mandatory packaging regulation called the Unique Device Identification (UDI) system, Puritan will be updating all packaging and labels with a code which will reflect certain criteria. To prepare our valued customers for this change, we recently sent out a letter stating that we have begun updating our products, and they can expect to see 4 major changes in our labels and packaging.

Puritan brand items, both sterile and non-sterile, will now include a lot number and expiration date. Non-sterile applicators will carry a 5 digit lot number while sterile products will continue to have a 4 digit lot number. All applicators, both sterile and non-sterile, will carry a 5 year expiration date. Dry transport tubes will continue to have a 3 year expiration date. Media-filled products have shorter expiration dates which vary by product type. The expiration date on all packaging now includes the first day of the month of manufacture (YYYY-MM-01). Media-filled products now utilize this same format, however the full date of manufacture is included (YYYY-MM-DD).

These new changes will not only fulfill the FDA’s requirements, but make it easier for our customers to access all details about each specific product in one place. If you have questions about these changes, please feel free to contact us.