Device Dossier

Oxygenator, extracorporeal membrane

Device Dossier for Oxygenator, extracorporeal membrane (Oxygenator, extracorporeal membrane, Class IIa, sponsor OHM Biomedical Engineering Services).…

Intended purpose

The Disposable Membrane Oxygenator 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, with a flow of up to 7.0 L/min.

TGA Public Summary