Device Dossier
Oxygenator, extracorporeal membrane
Device Dossier for Oxygenator, extracorporeal membrane (Oxygenator, extracorporeal membrane, Class IIa, sponsor BTC Cardio). ARTG record, intended…
- GMDN category: Oxygenator, extracorporeal membrane
Intended purpose
This medical device, in combination with perfusion Pump System, Tubing Set, Gas Blender and Heater-Cooler is intended to provide blood/gas exchange and regulate blood temperature in CardioPulmonary Support (C.P.S.). The device may include arterial filter or cardiotomy/ venous reservoir and contains an integrated heat exchanger.This is a single-use device.