Device Dossier

Hollow-fibre haemodialysis dialyser, high flux, single-use

Device Dossier for Hollow-fibre haemodialysis dialyser, high flux, single-use (Hollow-fibre haemodialysis dialyser, high flux, single-use, Class IIb,…

Intended purpose

Theralite 2100 hemodialyzers are intended to purify blood in hemodialysis. Theralite 2100 devices are indicated for patients suffering from acute renal impairment requiring dialysis for removal of plasma components up to 45 kDa in the context of myeloma cast nephropathy or rhabdomyolysis. Theralite 2100 devices are not intended for HDF (hemodiafiltration) or HF (hemofiltration) due to higher permeability of larger molecular weight proteins such as albumin. Theralite 2100 devices must not be used for pediatric dialysis and for regular treatment of chronic renal failure. Treatment with Theralite 2100 devices over a prolonged period of time may deplete essential proteins and generate hypoalbuminemia.

TGA Public Summary