NOO — Clamp, Dialysis Arm Class I
FDA product code NOO covers "Clamp, Dialysis Arm", a Class I medical device regulated under 21 CFR 876.5540. Submissions are reviewed by the Gastroenterology, Urology panel.
Classification Details
- Product Code
- NOO
- Device Class
- Class I
- Regulation Number
- 876.5540
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
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.