Product code ODX

Device name

Autonomous Extracorporeal Blood Leak Detector/Alarm

Medical specialty

Gastroenterology, Urology

Device class

2

Regulation number

876.5820

Review panel

GU

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

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.

Source

FDA openFDA device classification dataset