Device Dossier
oXiris Set - 973003 - Haemofilter - Haemofilter
Device Dossier for oXiris Set - 973003 - Haemofilter - Haemofilter (Haemofilter, Class III, sponsor Vantive). ARTG record, intended purpose, GMDN…
- 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 and CVVHDF.
Functional description
oXiris Set is a disposable single use extracorporeal circuit assembly on a support plate consisting of a heparin coated hollow fiber hemofilter/dialyzer connected to a blood access, blood return, dialysate inlet and effluent line with a 5L effluent bag. Other lines of the set are a replacement fluid, pre-blood pump and anticoagulant line. The membrane has a surface treatment and the inner side heparin coating acts as anti-thrombogenic agent. The membrane is diffusive, convective and adsorptive.