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Asahi AM-BIO Series Dialyzers are intended for use for hemodialysis treatment of patients who have chronic renal failure or acute renal failure. Asahi AM-BIO Series Dialyzers must be used in accordance with the instructions of a physician familiar with hemodialysis and familiar with the conditions of the patient. Asahi AM-BIO Series-Dialyzers have been tested in vitro and in confirmatory clinical studies under single or initial use and under reprocessing and reuse conditions for up to 15 reuse cycles. Based on the results from these evaluations, Asahi AM-BIO Series Dialyzers may be reprocessed for reuse 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 as recommended immediately below. It is noted that the Asahi AM-BIO Series Dialyzers have not been tested for reuse when reprocessed with agents and/or processes other than these, and the performance of the dialyzers under other conditions are not known and cannot be recommended. Accordingly: 1. The reprocessed dialyzer may be used only if the residual Total Cell Volume (TCV) is at least 80% of the original TCV and if such dialyzer otherwise meets the acceptance criteria of these instructions for use and the instructions of the reprocessing system utilized. Furthermore, the policies, instructions, and criteria of the institution for reuse (e.g., concerning dialyzer performance, residual blood, and/or dialyzer leakage or damage) should be followed. 2. The reprocessing agent may be either (1) 4% formaldehyde (also known as formalin) in conjunction with the Seratronics Dialyzer Reprocessing Systems for Dialyzer Reprocessing and Preparation (DRS4" and DPS4"), manufactured by Seratronics, Inc., or (2) Renalin® in conjunction with the Renatron® Dialyzer Reprocessing System (RS 8300), manufactured by Renal Systems, Inc. 3. The instructions provided by the manufacturer of the chosen reprocessing agent must be followed in reprocessing the dialyzer. 4. The reprocessed dialyzer may be used only on dialysis systems equipped with volumetric ultrafiltration controllers.

The line of Asahi AM-BIO Series Dialyzers is a family of hemodialysis membranes, or hollow fiber dialyzers developed to provide safe and effective hemodialysis over ranges of dialyzer patient treatment requirements. The device is intended for use in patients who have chronic renal failure or acute renal failure, for both single or initial use and when reprocessed for reuse for a maximum of 15 reprocessing reuse cycles on the same patient. The membrane fibers are made of modified cellulose (i.e., alkyl ether polymer grafted cellulose), derived from cuprammonium rayon. The cuprammonium rayon is manufactured to have a thin layer of modified cellulose exposed to blood contact surfaces. The modification to the cellulose yields the fiber more compatible to the patient's blood, manifested through lower complement activation (C3, and C5,) when compared to regular cellulose membrane dialyzers. The membranes are housed within a plastic casing of styrene butadiene block polymer. Nonremovable casing end caps are also made of styrene butadiene block polymer. The potting material (sealant) is polyurethane and the port caps (stoppers) are made of hydrogenated styrene butadiene block polymer. The AM-BIO Series Dialyzers will be offered for sale in both a "wet" model and a "dry" model. The wet and dry dialyzers are identical to each other except that the wet models are filled at the factory with a fluid to facilitate priming by the user and the dry models are not filled. The use of a wet or dry dialyzer is a matter of user preference. The fluid in wet dialyzers is made of water containing 600 ppm sodium pyrosulfite and 300 ppm sodium carbonate. All Asahi AM-BIO Series Dialyzers are sterilized before shipment by gamma radiation (y-rays). The dialyzer is no longer sterile after it is accessed for the initial use.

Hemoflow dialyzers are designed for use in acute or chronic hemodialysis therapies as either single use or multiple use.

Fresenius Polysulfone Hemodialyzers

Hemoflow dialyzers are designed for acute and chronic hemodialysis. Hemoflow dialyzers are also appropriate for single or multiple use when reprocessed with 1.5% Citric Acid/95℃.

The submission describes a procedure and components used in the reprocessing of Fresenius polysulfone hemodialyzers with 95°C/1.5% citric acid. This involves using radiant heat (moist or dry) at 95°C for 24 hours with the addition of 1.5% citric acid solution.

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.

Model CAHP-90 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. 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-90, CA-110, CA-130, and CA-150 Hemodialyzers

Asahi AM-R Series Dialyzers are intended for use for hemodialysis treatment of patients who have chronic renal failure or acute renal failure. Asahi AM-R Series Dialyzers have been tested in vitro and in confirmatory clinical studies under reprocessing and reuse conditions for up to 15 reuse cycles. Based on the results from these evaluations, Asahi AM-R Series Dialyzers may be reprocessed for reuse 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 as recommended immediately below. It is noted that the Asahi AM-R Series Dialyzers have not been tested for reuse when reprocessed with agents and/or processes other than these, and the performance of the dialyzers under other conditions are not known and cannot be recommended.. Accordingly: - (1) The reprocessed dialyzer may be used only if the residual Total Cell Volume (TCV) is at least 80% of the original TCV and if such dialyzer otherwise meets the acceptance criteria of the instructions for use and the instructions of the reprocessing system utilized. Furthermore, the policies, instructions and criteria of the institution for reuse (e.g., concerning dialyzer performance, residual blood, and/or dialyzer leakage or damage) should be followed. - (2) The reprocessing agent may be either (1) 4% formaldehyde (also known as formalin ) in conjunction with the Seratronics Reprocessing Systems for Dialyzer Reprocessing and Preparation (DRS4TM and DPS4TM), manufactured by Seratronics, Inc., or (2) Renalin® in conjunction with the Renatron® Dialyzer Reprocessing System, manufactured by Renal Systems, Inc. - The instructions provided by the manufacturer of the chosen reprocessing (3) agent must be followed in reprocessing the dialyzer. - The reprocessed dialyzer may be used only on dialysis systems equipped with (4) volumetric ultrafiltration controllers.

The AM-R Series Dialyzers are a family of hemodialyzers developed to provide safe and effective hemodialysis over ranges of dialyzer patient treatment requirements. The performance of these dialyzers, when new for single or initial (first) use and when reprocessed for reuse, have been documented through laboratory (in vitro) testing and confirmatory clinical testing. Assahi AM-R Series Dialyzers are constructed of hollow fiber membranes of cuprammonium rayon housed within a plastic casing of styrene butadiene block polymer. Asahi AM-R Series Dialyzers are sterilized before shipment by gamma radiation (y-rays). The dialyzer is no longer sterile after its sterile package is opened for the initial (first) use.