Device Dossier
oXiris Set - 973003 - Haemofilter
Device Dossier for oXiris Set - 973003 - Haemofilter (Haemofilter, Class III, sponsor Vantive). ARTG record, intended purpose, GMDN category — compiled…
- GMDN category: Haemofilter
- Sponsor: Vantive
Intended purpose
The oXiris set is a single use device that provides blood purification via diffusion, convection and adsorption through a semipermeable membrane. The oXiris set is for use only in conjunction with the PrismaFlex control unit or with the PrisMax control unit. The oXiris set is indicated for use in critically ill patients with a body weight equal or greater than 30 kg for hemoperfusion and / or renal replacement modalities such as SCUF, CVVH, CVVHD, CVVHDF.
Functional description
oXiris set is a disposable extracorporeal circuit for single use. The set consists of a heparin coated hollow fibre haemodialyser / filter, tubings for blood, dialysate, heparin, pre-blood pump fluid, reinfusion and effluent transport. A 5L effluent bag and a support plate for all components. The membrane has a surface treatment on the inner side and a heparin coating. The heparin grafting acts on the membrane as an anti-thrombogenic agent. The membrane is diffusive, convective and adsorptive.