Product code NOO

Device name
Clamp, Dialysis Arm
Medical specialty
Gastroenterology, Urology
Device class
1
Regulation number
876.5540
Review panel
GU
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Eligible
Definition
The device is a clamp used to close off needle holes in the arm of a Dialysis patient. The clamp applies uniform pressure to the sites of needle holes in the patient's arm until the holes close. The clamp pressure is designed to stop bleeding without causing blood clots. This is a different type of device than those listed in the classification regulation.
Source
FDA openFDA device classification dataset