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The Venofer Pump is an optional accessory for use with the Fresenius 2008 Series Hemodialysis Machines and is intended to administer Venofer® to treat iron deficiency anemia in patients with chronic kidney disease undergoing hemodialysis, where Venofer®, in conjunction with hemodialysis, is prescribed by a physician.

The Venofer Pump is an optional module for use on Fresenius 2008 Series Hemodialysis Machines and is designed to administer Venofer® during dialysis treatments and consists of a control panel, vial holder, fluid detector, and a peristaltic pump. The module is a self contained microprocessor controlled device that receives its power from the Fresenius 2008 Hemodialysis machine.

The 2008 Sorbent System is intended for adult acute and chronic uremic patients in the presence of a healthcare practitioner where hemodialysis is prescribed on the order of a physician.

The 2008 Sorbent System is intended for adult acute and chronic uremic patients in the presence of a healthcare practitioner where hemodialysis is prescribed on the order of a physician. The 2008 Sorbent System operates in a similar manner to standard hemodialysis systems currently approved for use; it is substantially equivalent to the Fresenius 2008T hemodialysis machine (K080964) and the Renal Solutions Allient® Sorbent Hemodialysis System (K070739). The significant difference between the 2008 Sorbent System and standard single-pass hemodialysis machines is that the 2008 Sorbent System utilizes a sorbent cartridge to purify dialysate made from potable tap water and then regenerates fresh dialysate from spent dialysate (like the Allient Sorbent Hemodialysis System). The 2008 Sorbent System consists of two distinct components: the 2008 Machine, and the SORB™ Module. The SORB Module is a sorbent dialysate regenerative system that attaches to the 2008 Machine and replaces the machine's existing single-pass dialysate delivery system. During treatment, used dialysate is chemically reprocessed into fresh, new dialysate and sent back to the dialyzer instead of being sent down a drain. By recirculating and regenerating the dialysate, the 2008 Sorbent System uses less than 15 liters of potable tap water per treatment compared to a standard single-pass system that uses at least 120 liters of purified water during a standard 4-hour dialysis treatment.

Fresenius Model 2008T Hemodialysis Machine is indicated for acute and chronic dialysis therapy. The Venofer® Pump Module is an optional accessory for use on Fresenius 2008T Hemodialysis Machines and is intended to administer Venofer®, an iron sucrose, to treat iron deficiency anemia in patients with chronic kidney disease undergoing hemodialysis, where Venofer®, in conjunction with hemodialysis, is prescribed by a physician.

The Venofer Pump Module is an optional module for use on Fresenius 2008T Hemodialysis Machines. The module is designed to administer Venofer, an iron sucrose supplement, during dialysis treatments. The Venofer Pump Module is to be used in accordance with the approved Venofer Indications for Use and the physician's prescription. The Venofer Pump Module is intended to provide ease and consistent delivery of Venofer, an iron sucrose supplement, indicated for the treatment of iron deficiency anemia for Hemodialysis dependent-chronic kidney disease patients. Anemia commonly occurs in patients with chronic kidney disease undergoing Hemodialysis and effective anemia management is recognized as an important factor in improving the outcomes of these patients. Iron deficiency is a frequent contributing factor which complicates the treatment of anemia in chronic kidney disease patients. Iron sucrose is commonly delivered to improve iron status in patients who have chronic kidney disease. Venofer is an injectable iron preparation drug approved for treatment of iron deficiency and is the most commonly used drug to treat iron deficiency anemia in dialysis patients. Renal Solutions has developed the Venofer Pump Module that provides the means to deliver Venofer when undergoing Hemodialysis on a Fresenius 2008T Dialysis System. The Venofer Pump Module fits into the module compartment of existing Fresenius 2008T Machines and consists of a control panel, vial holder, fluid detector, and a peristaltic pump.

The Allient Sorbent Hemodialysis System, including the SORB™ series and HISORB™ series of cartridges is to be used for the treatment of acute and chronic uremic patients where hemodialysis is prescribed by the physician.

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