Device Dossier

Cardiopulmonary bypass system centrifugal pump drive unit

Device Dossier for Cardiopulmonary bypass system centrifugal pump drive unit (Cardiopulmonary bypass system centrifugal pump drive unit, Class IIb,…

Intended purpose

The device is used with Disposable ECMO Set as an extracorporeal perfusion system intended to operate, control and monitor extracorporeal circulation. The system is intended for temporary respiratory/ cardiopulmonary support (up to 14 days) in adult patients that provides assisted extracorporeal circulation and physiologic gas exchange (oxygenation and CO2 removal), as well as thermoregulation of the patient's blood.

TGA Public Summary