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Autonomous Extracorporeal Blood Leak Detector/Alarm

FDA product code ODX · 4 cleared devices

Class 2 Gastroenterology, Urology
Regulation
21 CFR 876.5820
Review panel
GU
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2007-10-18 – 2013-11-22

To detect the presence of blood leaking from an extracorporeal connection or needle site in hemodialysis patients and alert the user or attending staff. The device detects colormetric, chemical, or light modulation caused by exposure to leaking blood.

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