Administration Set Securement Device

What Is It?

Accessory device that secures intravenous administration sets (IV lines/tubing) to mobile transport devices.

What Is FDA Product Code PUK?

Administration Set Securement Device is FDA product code PUK, Class 1, 21 CFR 880.5210.

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.