Device Dossier
Haemodialysis system, institutional
Device Dossier for Haemodialysis system, institutional (Haemodialysis system, institutional, Class IIb, sponsor Vantive). ARTG record, intended purpose,…
- GMDN category: Haemodialysis system, institutional
- Sponsor: Vantive
Intended purpose
The PrisMax control unit is intended for: Continuous Renal Replacement Therapy (CRRT) for patients with acute renal failure and/or fluid overload. Therapeutic Plasma Exchange (TPE) therapy for patients with diseases where removal of plasma components is indicated. Hemoperfusion (HP) for patients with conditions where immediate removal of substances by adsorption is indicated. Extracorporeal CO2 Removal (ECCO2R) for patients with conditions where extracorporeal elimination of carbon dioxide is indicated. All treatments administered via the PrisMax control unit must be prescribed by a physician.