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510(k) Data Aggregation

    K Number
    K021352
    Device Name
    DAYTON WATER SYSTEMS ULTRAPURE WATER TREATMENT SYSTEMS FOR HEMODIALYSIS
    Date Cleared
    2002-08-01

    (94 days)

    Product Code
    Regulation Number
    876.5665
    Why did this record match?
    Applicant Name (Manufacturer) :

    DAYTON WATER SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Dayton Water Systems' UltraPure Water Treatment System for Hemodialysis is intended for use in hemodialysis treatment. It is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate. When used as a medical device, Federal law restricts this device to sale by or on the order of a physician.
    Device Description
    UltraPure Water Treatment System For Hemodialysis (modified) with Pretreatment PH Citric Acid Feed System
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    K Number
    K981680
    Device Name
    ULTRAPURE WATER TREATMENT SYSTEM FOR HEMODIALYSIS
    Date Cleared
    1998-12-31

    (232 days)

    Product Code
    Regulation Number
    876.5665
    Why did this record match?
    Applicant Name (Manufacturer) :

    DAYTON WATER SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Dayton Water Systems' UltraPure Water Treatment System for Hemodialysis is intended for use in hemodialysis treatment. It is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate. When used as a medical device. Federal law restricts this device to sale by or on the order of a physician.
    Device Description
    The Dayton Water Systems' UltraPure Water Treatment System for Hemodialysis is a complete water purification system and consists of a reverse osmosis unit (RO) and/or deionizer exchange tanks (DI) to demineralize the water. Our recommendation to use RO and DI in conjunction or individually is based upon feed water quality and the demand of water to be used. Pretreatment includes activated carbon filtration media to remove organics, namely chlorine and chloramines. In order to optimize the performance of the RO system, the following items are utilized: 1) a water softener to remove scale-forming minerals: 2) cartridge filters to remove suspended solids: 3) a temperature blending valve to produce the desired water temperature. In order to compensate for fluctuations in demand, an air-tight storage tank with vent filter, level control, and internal spray array is utilized to store RO product water until needed. Repressurization pumps are employed to provide adequate flow and pressure to points of use. Whenever a storage tank or deionizer exchange tanks are used in a water purification system for hemodialysis, submicron membrane post filtration is used to remove any suspended solids and bacteria. Also, a temperaturecompensated quality-indicating device is installed on all systems utilizing deionizer exchange tanks. For additional safety, a remote audible/visual alarm is installed at the nurses' station to indicate any problems that may occur in the water treatment room. When feed water quality demands or when requested by the facility physician, optional devices can include the following components: 1) cartridge filtration for the removal of silt or feed water sediment: 2) automatic backwashing multimedia filter for the removal of suspended solids: 3) automatic backwashing carbon dioxide reduction filter (calcite filter) for the reduction/removal of CO2; 4) ultraviolet disinfection to reduce bacteria either in the influent water supply or on the product supply. 5) iodinator for the introduction of an iodine residual to the storage tank to inhibit bacteria growth (NOTE: DI tanks must be used to remove the residual iodine from the product water before use in hemodialysis treatment); and 6) a booster purnp to increase influent water pressure sufficient to provide adequate flow and pressure to the water treatment system.
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