Device Dossier
Haemodialysis unit
Device Dossier for Haemodialysis unit (Haemodialysis unit, Class IIb, sponsor Fresenius Medical Care). ARTG record, intended purpose, GMDN category —…
- GMDN category: Haemodialysis unit
- Sponsor: Fresenius Medical Care
Intended purpose
The NxStage System One is indicated for the treatment of acute and chronic renal failure or fluid overload using haemofiltration, haemodialysis and/or ultrafiltration in an acute or chronic care facility. The system is also indicated for haemodialysis with or without ultrafiltration in the home.