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The Omni System, which consists of the Omni-DL™ Control Unit, Omni-DL™ CVVHDF Kit, and 5 Liter Effluent Bag, is intended for use in renal replacement therapies in a hospital or clinical setting where CRRT is administered. Four different solute and fluid management therapies are available: - SCUF (Slow Continuous Ultrafiltration) - CVVH (Continuous Veno-venous Hemofiltration) - CVVHD (Continuous Veno-venous Hemodialysis) - CVVHDF (Continuous Veno-venous Hemodiafiltration)

The Omni-DLTM System (Omni System) provides continuous renal replacement therapies (hemodialysis, hemofiltration, hemodiafiltration, and ultrafiltration) in an intensive care setting for patients with acute renal failure and/or fluid overload. The Omni System consists of the Omni-DLTM Control Unit (Control Unit), the Omni-DLTM CVVHDF Kit (Omni Kit); a dedicated disposable tubing set which does not incorporate a hemofilter, and a separately packaged 5 Liter Effluent Bag. The Omni System is a continuous renal replacement therapy (CRRT) system intended for patients with acute renal failure and/or fluid overload. The Omni is indicated for continuous solute and or fluid removal in patients with acute renal failure and/or fluid overload. Blood access for therapy with the Omni System is via established methods of vascular access. The Omni System is designed for use on patients in a hospital setting to provide the following treatments: SCUF (Slow Continuous Ultrafiltration), CVVH (Continuous Veno-Venous Hemofiltration), CVVHD (Continuous Veno-Venous Hemodialysis), and CVVHDF (Continuous Veno-Venous Hemodiafiltration).