Bag, Urine Collection, Newborn

What Is FDA Product Code FOC?

Bag, Urine Collection, Newborn is FDA product code FOC, Class 2, 21 CFR 876.5250.

How Does It Reach the US Market?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.