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

The accessory ULTRALINE HDF is a single use sterile medical device. It is intended to be connected to ArtiSet/ PHYSIOSET blood tubing systems as listed into the Operator's Manual and to be used on ARTIS PHYSIO PLUS dialysis machines, to allow Hemodiafiltration (HDF) Double Needle treatment in pre or post dilution modality and Hemofiltration (HF) Double Needle treatment in pre dilution modality. It also allows on-line priming, bolus and rinseback of the blood circuit using infusion/substitution fluid delivered by the dialysis machine.