Device Dossier
Cardiopulmonary bypass system heat exchanger, single-use
Device Dossier for Cardiopulmonary bypass system heat exchanger, single-use (Cardiopulmonary bypass system heat exchanger, single-use, Class IIa, sponsor…
- GMDN category: Cardiopulmonary bypass system heat exchanger, single-use
Intended purpose
The Quantum PureFlow Standard Heat Exchanger is intended to be used with a compatible Heater/Cooler system to heat/cool blood during routine cardiopulmonary bypass (CPB) procedures up to 6 hours in duration. This is a single use device.