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Intravenous Catheter Force-Activated Separation Device.

FDA product code QOI · 7 cleared devices

Class 2 General Hospital
Regulation
21 CFR 880.5220
Review panel
HO
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2022-05-03 – 2024-09-06

An intravenous (IV) catheter force-activated separation device. An intravenous catheter force-activated separation device is placed inline with an intravenous catheter and an intravascular administration set, including any administration set accessories. It separates into two parts when a specified force is applied. The device is intended to reduce the risk of IV catheter failure(s) requiring IV catheter replacement.

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