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510(k) Data Aggregation
(30 days)
ELISIO™-H dialyzers are intended for hemodialysis, hemodiafiltration, hemofiltration, and isolated ultrafiltration in patients with acute kidney injury or chronic kidney disease when conservative therapy is judged to be inadequate.
The ELISIO™-H is a single-use, high-flux hemodialyzer intended for the extracorporeal treatment of patients with renal failure. The device is constructed of a plastic cylindrical housing comprised of two compartments, one for blood and one for dialysate, separated by a semi-permeable membrane. Blood is circulated through the blood compartment, while dialysate flows counter currently through the dialysate compartment. This flow pattern enables the removal of uremic toxins, excess fluid, and electrolytes via diffusion and/or convection, depending on the selected treatment modality.
The dialyzer interfaces with the patient via an ISO 8637 compliant blood tubing set and must be used with dialysis machines equipped with an ultrafiltration controller or accurate fluid balancing system. The ELISIO™-H features the POLYNEPHRON™ membrane (Polyethersulfone), for high clearance efficiency and a polypropylene housing not made with BPA or DEHP.
The device is available in eight sizes (surface area): 0.9, 1.1, 1.3, 1.5, 1.7, 1.9, 2.1, and 2.5 m². It is sterile (gamma radiation) and non-pyrogenic with a three-year shelf life. No integrated components or accessories are included.
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