Search Results

VIE-U is intended for use in hemodialysis for the treatment of patients who have acute or chronic renal failure. ViE-U is intended for single use only.

The ViE-U is a high flux hollow fiber hemodialyzer. The device is sold sterile and is intended for single use only. All the materials including the hollow fiber membrane, housing, headers, potting material and stoppers are identical to those previously cleared in the predicate device (APS). The additional coating of vitamin E on the hollow fiber membrane uses an equivalent material and technology to the predicate device (CLIRANS).

REXEED-S Series Dialyzer is intended for use in hemodialysis for the treatment of patients suffering from acute or chronic renal failure.

The line of Asahi REXEED-S Series Dialyzer (hereafter referred to as REXEED-S) is a family of high permeability hollow fiber dialyzers intended for the treatment of patients with acute or chronic renal failure. REXEED-S is designed for single use. REXEED-S is constructed of hollow fiber membrane housed within a plastic housing of Styrene-Butadiene block copolymer and is subject to gamma-ray irradiation prior to shipment.

A. REXEED-SX/LX Dialyzers is intended for use for hemodialysis treatment of patients who have chronic or acute renal failure. B. REXEED SX/LX Dialyzers must be used in accordance with the instructions for a physician familiar with hemodialysis and familiar with the conditions of the patient. C. REXEED SX/LX Dialyzers have been tested in vitro under single use conditions.

The line of Asahi REXEED-SX/LX Series Dialyzer is a family of high permeability hollow fiber dialyzers intended for the treatment of patients with acute or chronic renal failure. REXEED-SX/LX Series Dialyzer is designed for single use. REXEED-SX/LX Series Dialyzer is constructed of hollow fiber (polysulfone) membranes, housed within a plastic casing of styrene-butadiene block copolymer and are subjected to electron beam irradiation prior to shipment.

A. REXEED-SX/LX Dialyzers is intended for use for hemodialysis treatment of patients who have chronic or acute renal failure. B. REXEED SX/LX Dialyzers must be used in accordance with the instructions for a physician familiar with hemodialysis and familiar with the conditions of the patient. C. REXEED SX/LX Dialyzers have been tested in vitro under single use conditions.

The line of Asahi REXEED-SX/LX Dialyzers is a family of high permeability hollow fiber dialyzers intended for the treatment of patients with acute or chronic renal failure. REXEED-SX/LX Dialyzers are designed for single use. REXEED-SX/LX Dialyzers are constructed of hollow fiber (polysulfone) membranes, housed within a plastic casing of styrene-butadiene block copolymer and are subject to electron beam irradiation prior to shipment. This Special 510(k) describes the following modifications: - Change in wall thickness of the polysulfone REXEED-SX/LX hollow fibers to 35 um, compared to 45 um for the existing predicate APS/REXEED - Change in priming procedure to REXEED-SX/LX priming procedure (drytype) from APS/REXEED priming procedure (wet-type) - Change in sterilization type to electron beam irradiation REXEED-SX/LX Dialyzers, compared to gamma radiation for the existing predicate APS/REXEED - Change in use to REXEED-SX/LX is available for single use from APS/REXEED which is available for single use and reuse.

REXEED Series Dialyzers is intended for use for hemodialysis treatment of patients who have chronic or acute renal failure. REXEED Series Dialyzers must be used by a physician familiar with hemodialysis and under single or initial use conditions. REXEED Series Dialyzers have been evaluated under reprocessing and reuse conditions for all REXEED-UR/R Series Dialyzers. Based on the results from these evaluations, REXEED-UR/R Series Dialyzers may be reprocessed for reuse on the same patient. If reprocessing Series Dialyzers may be reprocessed for reuse on the same patient. If reprocessing is elected, it is recommended that the reuse be done under the conditions as existed in the in vitro and confirmatory clinical studies as conditions as "Existed" in "the "in "the "ht" "ht" "hat REXEED-UR/R Series Dialyzers recommisinced inimediately corrent 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 The reprocessed that 20% of the original TCV and if such dialyzer otherwise meets (TCV) is at least 60% of these instruction for use and the instruction of the the acceptance officilized. Furthermore, the policies, instructions, and criteria reprocessing system annized. Furthernore, mag dialyzer performance, residual of the ind/or dialyzer leakage or damage) should be followed. (2) The reprocessing agent may mixture of hydrogen peroxide and peroxyacetic The reprocessing agent may intinues of 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 REXEED Series Dialyzers (hereinafter called REXEED) is a family of high permeability hollow fiber dialyzers intended for the treatment of patients with acute or chronic renal failure. REXEED-U/S are designed for single use and REXEED-UR/R are designed for reuse. The REXEED dialyers are constructed of reusable hollow fiber (polysulfone) membranes, housed within a plastic casing of styrene butadiene block copolymer and are gamma sterilized prior to shipment. Modifications made in this 510(k) including the followings. (1) The shape modification of polysulfone hollow fibers to the crimped was implemented. The REXEED dialyzers with crimped hollow fibers is added to the existing APS Series Dialyzers (hereafter called APS) cleared under K001250 and; (2) the REXEED dialyzers membrane surface area ranges from 1.5m² to 2.5m², while that of APS ranges from 0.8 m² to 2.1 m² and; (3) mixture of hydrogen peroxide and peroxyacetic acid (e.g., Renalin®) is used as reprocessing agent) and; (4) accordingly, change in the Instruction For Use (IFU) in regard to reprocessing agent.