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Gambro FH 22H Fiber Hemofilter

The Centrysystem 14 PES Gamma can be used whenever hemodialysis is indicated. This dialyzer can be used for long term chronic hemodialysis as well as for acute hemodialysis. In hemodialysis therapy, monitoring of patient vital signs, the dialysate delivery system, heparin administration, and clotting times should be performed under the direction of a physician.

The membrane used in this device is polyether sulfone which is substantially equivalent to the polysulfone membrane utilized in the Fresenius F80A dialyzers and the polyether sulfone membrane utilized in the Gambro HC 14 R Hemoconcentrators. Both devices have been previously approved for marketing in the United States under 510K Notifications. The polyether sulfone membrane is manufactured by Gambro. Blood enters a blood inlet port where it is distributed to polyether sulfone hollow fiber has an inner diameter of approximately 215 microns and a wall thickness of 50 microns. The effective length of the fibers is 267 mm. The fibers used in this device are substantially equivalent in design to the previously approved Gambro HC 14R Hemoconcentrator. The patient's blood traverses the inside of the hollow fibers and exits the device via a blood exit port. By means of a hydrostatic pressure or transmembrane pressure which is created by a combination of positive and negative pressures across the Polyether sulfone membrane, plasma water along with certain lower molecular weight solutes of plasma water pass through the membrane and into the dialysate Removal of uremic toxins and waste products are removed from the compartment of the devices. patient's blood in this device by means of both diffusion and convection through the Polyether sufone membrane into the counter current flowing dialysis solution. The dialysate exits the devices via a dialysate outlet port.

The Gambro Polyflux 14, 17, and 21 hemodialyzers can be used whenever hemodialysis is indicated. This dialyzer can be used for long term chronic hemodialysis as well as for acute hemodialysis. In hemodialysis therapy, monitoring of patient vital signs, the dialysate delivery system, heparin administration, and clotting times should be performed under the direction of a physician.

The membrane used in these devices is Polyamide which is identical to the polyamide membrane utilized in the Gambro Polyflux 11 dialyzers which have been previously approved for marketing in the United States under a 510K Notification (K933818). This membranes is manufactured by Gambro Dialysatoren of Germany. Blood enters a blood inlet port where it is distributed to polyamide hollow fibers. Each hollow fiber has an inner diameter of approximately 220 microns and a wall thickness of 50 microns. The effective length of the fibers is 210 mm for the Polyflux 14 and 250 mm for the Polyflux 17 and 21. The fibers used in this device are substantially equivalent in design to the previously approved Gambro Polyflux 11 hemodialyzers. The patient's blood traverses the inside of the hollow fibers and exits the device via a blood exit port. By means of a hydrostatic pressure or transmembrane pressure which is created by a combination of positive and negative pressures across the Polyamide membrane, plasma water along with certain lower molecular weight solutes of plasma water pass through the membrane and into the dialysate compartment of the devices. Removal of uremic toxins and waste products are removed from the patient's blood in this device by means of both diffusion and convection through the Polyamide membrane into the counter current flowing dialysis solution. The dialysate exits the devices via a dialysate outlet port.

The Centrysystem 600 HG can be used whenever hemodialysis is indicated. This dialyzer can be used for long term chronic hemodialysis as well as for acute hemodialysis. In hemodialysis therapy, monitoring of patient vital signs, the dialysate delivery system, heparin administration, and clotting times should be performed under the direction of a physician.

The membrane used in this device is Hemophane which is substantially equivalent to the Hemophane membrane utilized in the Gambro GFS Plus 20 dialyzers which have been previously approved for marketing in the United States under a 510K Notification (K902481). Both of these membranes are manufactured by Akzo (Enka) of Germany. Blood enters a blood inlet port where it is distributed to Hemophane hollow fibers. Each hollow fiber has an inner diameter of approximately 200 microns and a wall thickness of 6.5 microns. The effective length of the fibers is 267 mm. The fibers used in this device are substantially equivalent in design to the previously approved Gambro GFS Plus hemodialyzers. The patient's blood traverses the inside of the hollow fibers and exits the device via a blood exit port. By means of a hydrostatic pressure or transmembrane pressure which is created by a combination of positive and negative pressures across the Hemophane membrane, plasma water along with certain lower molecular weight solutes of plasma water pass through the membrane and into the dialysate compartment of the devices. Removal of uremic toxins and waste products are removed from the patient's blood in this device by means of both diffusion and convection through the Hemophane membrane into the counter current flowing dialysis solution. The dialysate exits the devices via a dialysate outlet port.