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510(k) Data Aggregation

    K Number
    K082400
    Device Name
    DEIONIZER AND CARBON EXCHANGE SERVICE FOR HEMODIALYSIS
    Date Cleared
    2009-02-03

    (167 days)

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

    CULLIGAN SOFT WATER SERVICE CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Culligan Soft Water Service Company Deionizer and Carbon Exchange tanks are primary or temporary devices to provide water for hemodialysis applications per the requirements of ANSI/AAMI RD62. These tanks remove chlorine, chloramines, total organic carbons and total dissolved solids from water used to dilute dialysis concentrate to form dialysate, in reprocessing of hemodialyzers, as supply water to the dialysis machines and equipment rinse and disinfection. Upon exhaustion, these tanks will be replaced with other tanks containing newly regenerated resin, or with new resin altogether. These tanks are components of a larger water treatment system employing adequate pre-treatment and post-treatment sections. Culligan's tanks are not to be used alone.
    Device Description
    The Culligan Soft Water Service Company, Deionizer and Carbon Exchange Service for Hemodialysis includes carbon filtration for the removal of chlorine and chloramines and deionizer (DI) exchange tanks for the removal of contaminants from the water through an ion exchange process to provide AAMI quality water for hemodialysis applications.
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