FDA Product Code ODX: Autonomous Extracorporeal Blood Leak Detector/alarm
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.
Leading manufacturers include Redsense Medical AB.
4
Total
4
Cleared
195d
Avg days
2007
Since
FDA 510(k) Cleared Autonomous Extracorporeal Blood Leak Detector/alarm Devices (Product Code ODX)
4 devices
Cleared
Nov 22, 2013
REDSENSE ALARM SYSTEM
Redsense Medical AB
Gastroenterology & Urology
263d
Cleared
Oct 18, 2007
REDSENSE
Redsense Medical AB
Gastroenterology & Urology
191d