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POLYFLUX LR is intended for use in hemodialysis for the treatment of acute and chronic renal failure. The POLYFLUX LR may be reprocessed for reuse on the same patient.

The Gambro POLYFLUX 6 LR, 8 LR, and 10 LR, Capillary Dialyzers labeled for multiple use / reuse are identical in design, materials, function and intended use to the Gambro POLYFLUX 6L, 8L, and 10L Capillary Dialyzers/ Filters labeled for single use which have been previously cleared by the FDA under a 510(k) Notification for single use (510(k) Notification K010985). These devices are intended for use in hemodialysis for the treatment of acute and chronic renal failure and for certain types of intoxications. They may also be used in cases of acute fluid overload for the removal of plasma water. The membrane used in this device is polyarylethersulfone (PES) which is identical to the membrane utilized in the Gambro POLYFLUX 6L, 8L, and 10L Capillary Dialyzers/ Filters labeled for single use which have been previously cleared for marketing in the United States under 510K Notifications (K010985). Blood enters a blood inlet port where it is distributed to the hollow fibers. Each hollow fiber has an inner diameter of approximately 215 microns (wet hollow fiber internal diameter) and a wall thickness of 50 microns. The number of hollow fibers in each hemodialyzer / filter is 10,00 for the POLYFLUX 6 LR, 10,000 for the POLYFLUX 8 LR, and 12,500 for the POLYFLUX 10 LR. This effective membrane length is 210 mm for the POLYFLUX 6 LR, and 250 mm for the POLYFLUX 8 LR and 10 LR. The effective membrane surface area is 1.4 square meters for the POLYFLUX 6 LR, 1.7 square meters for the 8 LR and 2.1 square meters for the 10 LR. The housing and end caps of this hemodialyzer / filter are made of polycarbonate. The fibers used in the Gambro POLYFLUX 6 LR, 8 LR, and 10 LR are of the same composition as those previously approved for the Gambro POLYFLUX L 6L, 8L, and 10L Capillary Dialyzers/ Filters labeled for single use and multiple use (K010985). 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 membrane, plasma water along with certain lower molecular weight solutes pass through the membrane and into the dialysate or filtrate compartment of the device. 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 membrane and into the counter current flowing dialysis solution during hemodialysis. The dialysate exits the devices via a dialysate outlet port.

POLYFLUX R is indicated for use in hemodialysis for the treatment of chronic or acute renal failure. The choice of the filter is the responsibility of the physician. Special attention must be paid in connection with pediatric use. CAUTION! If POLYFLUX R is reused, the procedure and disinfection specified in the RENATRON INSTRUCTION MANUAL must be followed. The POLYFLUX R may be reprocessed for reuse on the same patient.

The Gambro Polyflux 17R and 21R, Capillary Dialyzers/Filters labeled for multiple use (reuse) are identical in construction in function to Gambro Polyflux 17S and 21S Hemodialyzers / Hemofilters labeled for single use which are currently marketed in the United States and have been previously cleared by the FDA under 510(k) Notification K981414. Only the product designation "R" has been changed from "S" to designate that they are labeled for multiple use (reuse). These devices are intended for use in hemodialysis for the treatment of acute and chronic renal failure and for certain types of intoxications for both single when reprocessed for reuse for a maximum of 15 reprocessing reuse cycles on the same patient. If reprocessing and reuse is practiced, it is recommended that the reuse be done under the conditions as existed in the in vitro and confirmatory clinical studies undertaken by Gambro and presented in the labeling for this device. It may also be used in cases of acute fluid overload for the removal of plasma water. The membrane used in these devices is polyethersulfone (PES) which is identical to the membrane utilized in the Gambro Polyflux 17S and 21S Hemodialyzers / Hemofitters for labeled for single use which have been previously approved for marketing in the United States under a 510K Notification (K982414). Blood enters a blood inlet port where it is distributed to polyethersulfone hollow fibers. Each hollow fiber has an inner diameter of approximately 215 microns (wet hollow fiber internal diameter) and a wall thickness of 50 microns. The number of polyethersulfone hollow fibers in each hemodialyzer / hemofilter is 10,000 for the Polyflux 17R and 12,500 for the 21R. These dialyzers have an effective membrane length of 250 mm. The effective membrane surface area is 1.7 square meters for the 17R and 2.1 square meters for the 21R. The housing and end caps of these hemodialyzers / hemofiters are made of polycarbonate. The fibers used in the Gambro Polyflux 17R and 21R are identical in design and materials to the previously approved Gambro Polyflux 17S and 21S Hemodialyzers / Hemofilters for labeled for single use (K982414). 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 polyethersulfone membrane, plasma water along with certain lower molecular weight solutes of plasma water pass through the membrane and into the dialysate or filtrate compartment of the device. 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 polyethersulfone membrane and into the counter current flowing dialysis solution during hemodialysis. The dialysate exits the devices via a dialysate outlet port.

Altra Fluxed 200 Heinodialyzers are intended for acule or chronic Hemodialysis. Hemodiatysis is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. The Altra Flux 200 Hemodialyzer is indicated for single use or multiple use with the same patient.

The Altra Flux® 200 multiple use hemodialyzer is the Altra Flux® 200 single use device with reuse labeling. Like the Altra Flux® 200 single use device, it is used as an artificial kidney in a hemodialysis system to treat patients with acute or chronic renal failure. The blood from a patient flows through the arterial tubing of the extracorporeal blood circuit to the blood compartment of the hemodialyzer, then returns through the venous tubing of the extracorporeal blood system to the patient. The hemodialyzer has semipermeable hollow fibers which divide the device into two compartments. When the blood passes through the hollow fibers, water and toxic waste products from the blood pass through the semipermeable membrane into the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the hemodialyzer. A high permeability hemodialyzer has a semipermeable membrane that is more permeable to water than that of the conventional dialyzer. This device must be used in conjunction with a controlled dialysate delivery system that incorporates an ultrafiltration controller to prevent excessive loss of water from the patient's blood. This highly permeable, semipermeable membrane may also permit greater loss of high molecular weight substances from the blood, compared with the conventional hemodialyzer.

Altra Nova® 200 Hemodialyzers are intended for acute or chronic Hemodialysis. Hemodialysis is indicated for patients with acute or chronic result failure when conservative therapy is judged to be inadequate. The Altra Nova 200 Hemodialyzer is indicated for single use or multiple use with the same patient.

The Altra Nova® 200 multiple use hemodialyzer is the Altra Nova® 200 single use device with reuse labeling. Like the Altra Nova® 200 single use device, it is used as an artificial kidney in a hemodialysis system to treat patients with acute or chronic renal failure. The blood from a patient flows through the arterial tubing of the extracorporeal blood circuit to the blood compartment of the hemodialyzer, then returns through the venous tubing of the extracorporeal blood system to the The hemodialyzer has semipermeable hollow fibers which divide the patient. device into two compartments. When the blood passes through the hollow fibers, water and toxic waste products from the blood pass through the semipermeable membrane into the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the hemodialyzer. A high permeability hemodialyzer has a semipermeable membrane that is more permeable to water than that of the conventional dialyzer. This device must be used in conjunction with a controlled dialysate delivery system that incorporates an ultrafiltration controller to prevent excessive loss of water from the patient's blood. This highly permeable, semipermeable membrane may also permit greater loss of high molecular weight substances from the blood, compared with the conventional hemodialyzer.

Hemodialysis with these dialyzers is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. It may also be indicated in the treatment of patients intoxicated with poisons or drugs. These dialyzers are indicated for single use or reuse. If the dialyzer is reused on the same patient, the reuse procedure and disinfectant specified in the Direction Insert must be followed. No other reuse procedure or disinfectant has been evaluated for clinical acceptability.

Models CAHP-110, CAHP-130, CAHP-150, CAHP-170, CAHP-210 Hemodialyzers

Hemodialysis with these dialyzers is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. It may also be indicated in the treatment of patients intoxicated with poisons or drugs. This dialyzer is indicated for single use or reuse. If the dialyzer is reused on the same patient, the reuse procedure and disinfectant specified in the Direction Insert must be followed. No other reuse procedure or disinfectant has been evaluated for clinical acceptability.

Models CA-170, and CA-210 Hemodialyzers

The Primus® Hollow Fiber Dialyzer is indicated for hemodialysis of patients with acute or chronic renal insufficiency. The Primus Dialyzer is intended for reuse.

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