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510(k) Data Aggregation

    K Number
    K092481
    Device Name
    HEMODIALYSIS CARBON EXCHANGE, DUAL BED DEIONIZER EXCHANGE, MIXED BED DEIONIZER EXCHANGE, MODEL .60MAW,1.2MAW,3.6MAW, 1.2
    Date Cleared
    2010-04-02

    (232 days)

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

    NEW AQUA LLC (DBA AQUA SYSTEMS)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Deionizer and Carbon Exchange Service for Hemodialysis are intended to be used in a hemodialysis facility according to AAMI standards to supply purified water for use in hemodialysis applications per the requirements of ANSI/AAMI RD62. The exchange tanks can be used for either primary water purification or to supply emergency backup water purification for dialysis. These exchange tanks are components of a larger water treatment system employing adequate pretreatment and post treatment sections. These tanks are not to be used alone. Upon exhaustion, these tanks will be replaced with other Deionization Tanks containing newly regenerated resin or with new resin altogether, or in the case of Carbon Tanks, with tanks containing fresh virgin carbon.
    Device Description
    New Aqua LLC Deionizer and Carbon Filter exchange tanks for Dialysis are FRP tanks filled with high purity DI resins for the Deionizers and acid washed carbon for the carbon filters. Union style connectors are used in conjunction with a molded Noryl head, PVC riser pipe and distributor basket. The tanks are designed to supply AAMI standard water for dialysis through ion exchange. The tanks are based on the AmeriWater Dialysis Deionizer Exchange Tanks K991519.
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