8000 Perfusion System Safety Monitor Providing Air Bubble and Fluid Level Detection Display.

8000 Perfusion System Safety Monitor Providing Air Bubble and Fluid Level Detection Display.
Sarns™ Modular Perfusion System 8000 - 16404

A mains electricity (AC-powered) device designed to detect air bubbles in blood returned to the body from the extracorporeal circuit of a cardiopulmonary (heart-lung) bypass system, and to detect when blood falls below acceptable levels, typically in the venous drip chamber. The device typically consists of an electronic unit and ultrasonic sensors; it usually triggers alarms and activates automated mechanisms to turn off the blood flow when bubbles are detected or an abnormal fluid level occurs. It is typically an integral part of the cardiopulmonary bypass system.

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No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: DTW

Device Name: Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 870.4340

Third Party Flag: N

Medical Specialty: CV

Code: KRL

Device Name: Detector, Bubble, Cardiopulmonary Bypass

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 870.4205

Third Party Flag: Y

Medical Specialty: CV

Device Id: 00886799000199

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A