Device Dossier

Oxygenator, extracorporeal membrane

Device Dossier for Oxygenator, extracorporeal membrane (Oxygenator, extracorporeal membrane, Class IIa, sponsor Spectrum Medical). ARTG record, intended…

Intended purpose

Quantum Perfusion Blood Oxygenator with Integrated AF VT75-C2 is designed to oxygenate and remove carbon dioxide from venous blood and is used: (i) as pulmonary support during procedures requiring cardiopulmonary bypass for periods of up to 6 hours; (ii) as pulmonary support during extracorporeal procedures not requiring cardiopulmonary bypass for periods of up to 6 hours; (iii) to measure blood temperature during the procedure; (iv) to remove air bubbles and parti culate larger than 40 μm.

TGA Public Summary