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510(k) Data Aggregation

    K Number
    K153329
    Device Name
    MED-TECH Water Systems Inc Exchangeable Carbon Tanks for Dialysis
    Date Cleared
    2016-08-04

    (259 days)

    Product Code
    Regulation Number
    876.5665
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    Applicant Name (Manufacturer) :

    MED-TECH WATER SYSTEMS INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MED-TECH Water Systems Inc. Exchangeable Carbon Tanks are intended to be used as a component of a hemodialysis water purification system designed to pretreat and purify potable water for hemodialysis applications. The exchange tanks are intended for use in complete water purification systems employing adequate pretreatment and post-treatment in accordance with current AAMI standards. The exchange tanks are not intended to be used alone. They are intended to remove chlorine and chloramines from water that will be purified by the water purification system and used for hemodialysis applications. Upon exhaustion, these tanks will be replaced with other tanks containing new activated carbon.
    Device Description
    MED-TECH Water Systems Inc. Exchangeable Carbon Tanks for Dialysis are Fiberglass Reinforced Polypropylene (FRP) tanks filled with new virgin coal based granular activated carbon (GAC). The carbon media removes chlorine, chloramines, and other organics from the source water through the chemical process of adsorption. Only new virgin coal based granular activated carbon (GAC) of 12X40 mesh size with an iodine number of 1000 or greater is used in the exchange tanks.The tank sizes are range from 6" x 18" through 16" x 65" common for the dialysis industry. The Carbon Exchange Tanks are dedicated for carbon only. MED-TECH Water Systems Inc. recommends that tanks be installed in worker/polisher configuration with the first tank providing the primary purification and the second tank serving as a polisher and back-up to the primary purification.
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