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.