Device Dossier

Tubing set, dialysis/haemodialysis

Device Dossier for Tubing set, dialysis/haemodialysis (Tubing set, dialysis/haemodialysis, Class IIa, sponsor Vantive). ARTG record, intended purpose,…

Intended purpose

C-705 Accessory Expansion Chamber is a single use sterile medical device intended to be used to allow the conversion from Double Needle to Single Needle administration mode of treatments, after connection to proper Blood Tubing System intended for Hemodialysis treatment in Double Needle mode and to a Dialyzer filter. C-705 Accessory Expansion Chamber shall be used in combination with Blood Tubing System suitable for AK 96, AK 98 v1, v2 and v3, AK 200 S and AK 200 ULTRA S hemodialysis delivery systems only.

TGA Public Summary