Profile: Oita Works, Asahi Kasei Kuraray Medical Co., Ltd. provides therapeutic automated blood cell and plasma separator & hollow fiber capillary dialyzers.
FDA Registration Number: 8010002
US Agent: Kazunori Nakayama / Asahi Kasei Medical America Inc.
Phone: +1-(847)-641-5904 E-Mail:
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• Artifical Eye Cleaning/Lubricating Solution (FDA Code: MSI) |
• Blood Transfusion Microfilter (FDA Code: CAK / 880.5440) An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container. |
• High Flux Re-Use Hemodialyzer (FDA Code: MSF / 876.5860) A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system (876.5820), the high permeability hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of the following devices: |
• High Permeability with/without Sealed Dialysate System (FDA Code: KDI / 876.5860) |
• Hollow Fiber Capillary Dialyzer (FDA Code: FJI / 876.5820) A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer. |
• Low Flux Re-Use Hemodialyzer (FDA Code: MSE / 876.5820) |
• Membrane Automated Blood Cell/Plasma Separator For Therapeutic Purposes (FDA Code: MDP) |
• Therapeutic Automated Blood Cell and Plasma Separator (FDA Code: LKN) |