Device Dossier

HD Concentrates - Bibag, Sobag & Indibag - Dialysate, haemodialysis

Device Dossier for HD Concentrates - Bibag, Sobag & Indibag - Dialysate, haemodialysis (Dialysate, haemodialysis, Class IIb, sponsor Fresenius Medical…

Intended purpose

Haemodialysis concentrate (in powder or liquid presentation) used ro produce dialysate for dialysis. BiBag contains sodium bicarbonate powder for on-line production of Part B, Sobag contains sodium chloride powder & Indibag is a 2-chamber bag of electrolytes & glucose solutions for on-line production of Part A.

TGA Public Summary