NEW STERILE PACKAGING
We have completed the initial phase of our modernization project for the individual packaging of our sterile product. We have replaced the old
polybag pouch, which we have been using since the inception of the product in 1977, with a medical grade paper / film pouch.
This pouch features the peel to open capability that is now prevalent in the medical and healthcare industry.
The packaging also features data information not previously available on our old packaging.
New Features on the packaging include:
Symbology common in industry for STERILE by IRRADIATION, DO NOT USE IF DAMAGED, LATEX FREE, ONE-TIME USE ONLY, and
COMPONENT MATERIALS POLYPROPYLENE and POLYSTYRENE.
On the Data Label:
STOCK NUMBER, LOT NUMBER, MANUFACTURE DATE, EXPIRATION DATE,
STERILIZATION LOAD NO and the individual device UPC BAR CODE.
ALL STERILE PRODUCTS: 101 / 301; 105 / 305 AND 110 / 310 are now shipping in this new configuration.
At a future date, as the final phase of the modernization project, we will be implementing the FDA UDI feature with the GUDID database.
This will create the smart barcode that will include STOCK NO, LOT NUMBER, MANUFACTURE DATE and EXPIRATION DATE in a single barcode.
As our device is a class I device, the compliance date is currently set for September 2020 thru September 2024.
We plan to be in compliance way before the 2024 date.
Ashton Pumpmatic, Inc.
7670 McEwen Road, Dayton, OH 45459-3908
800-395-1012 • 937-424-1380