Interpower announces that it can provide serial numbers on medical cords according to a company’s specific request. While medical cords are not classified as a medical device, companies may choose to identify their cords as a part of the Unique Device Identification (UDI) System, a new process being mandated by the FDA.
Increasing concerns about product recalls, counterfeit devices and patient safety has led the FDA to start an UDI System in regards to most medical devices. The UDI is a unique numeric or alphanumeric code which includes a uniform list of product identifiers. Currently identification methods are fragmented and it is difficult to trace the original product back to the manufacturer.
The FDA’s “UDI System Final Rule” was issued in September 2013. As with many new laws, there are several different compliance dates, depending on the type of medical device, whether it is a Class III, II or I. For a complete list of compliance dates, check out the FDA website.
There are three steps to take to be in compliance:
- Create and assign the UDI.
- Choose the right labeling software to label the products with the UDI.
- Submit and store the UDI in the Global Unique Device Identification Database (GUDID).
While medical cords are not classified as a medical device by the FDA, Interpower offers serial numbers on medical cords per a client’s specific requirements.