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,…

GMDN category: Tubing set, dialysis/haemodialysis
Sponsor: Vantive

Intended purpose

The accessory ULTRALINE HD 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 assure priming, bolus and rinseback in Hemodialysis (HD) Double Needle (DN) and Single Needle (SN) treatments with infusion fluid delivered on-line by the dialysis machine.