Search Results
Found 1 results
510(k) Data Aggregation
(189 days)
The multiFlux 130 and 160 filters are intended for single use only for extracorporeal blood purification during continuous veno-venous hemofiltration (CVVH), continuous veno-venous hemodialysis (CVVHD), and continuous veno-venous hemodiafiltration (CVVHDF) using pre-, post- or mixed-dilution modes for patients suffering from acute kidney injury.
The multiFlux 130 and 160 hemofilters are high-flux, single-use, steam-sterilized filters. The hemofilters are provided blood pathway sterile and non-pyrogenic. The hemofilters allow for the transfer of water and solutes between blood and dialysate using semipermeable, hollow fiber membranes.
The multiFlux 130 and 160 hemofilters are high-flux, sterile devices designed for single-use acute hemodialysis. The hemofilters are configured to connect to a bloodline set which connects to a patient's vascular access system when used with a hemodialysis machine equipped with ultrafiltration control. During hemodialysis, blood is pumped from the patient's body through an extracorporeal circuit, one component of which is the hemofilters. The hemofilters contain semi-permeable membranes that allow for diffusion and/or ultrafiltration to transport toxins and excess fluid from the blood compartment (fiber lumen) to the dialysate compartment. Hemofilters utilize a counter-current flow in which dialysate and blood flow in opposite directions in the hemofilter. The counter-current flow maintains the concentration gradient across the membrane for waste and fluid removal.
The multiFlux 130 and 160 hemofilters' components are composed of the following materials:
Housing: Polypropylene
Potting Resin: Polyurethane
Fiber Bundle: Polysulfone-polyvinylpyrrolidone blend, alpha-tocopherol (vitamin E)
Sealing Ring: Silicone
Flange: Polypropylene
Blood Port Cap(s): Polypropylene
Dialysate Port Cap(s): Styrol-Ethylen-Butylen-Styrol, Polypropylene
N/A
Ask a specific question about this device
Page 1 of 1