Device Dossier
Apheresis unit
Device Dossier for Apheresis unit (Apheresis unit, Class IIb, sponsor Getz Healthcare). ARTG record, intended purpose, GMDN category — compiled by…
- GMDN category: Apheresis unit
Intended purpose
The Plasma Collection Machine is a device designed for blood component separation and collection. This is achieved by means of computer controlled and automated blood separation technology. Components collected by the Plasma Collection Machine include plasma for use in therapeutic transfusion and source plasma which is conserved and subsequently fractionated. The Plasma Collection Machine is designed to be used with a single use disposable set which provides a sterile pathway for the blood collection, separation and component collection.