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510(k) Data Aggregation

    K Number
    K133724
    Device Name
    MINNCARE HD
    Manufacturer
    MEDIVATORS, INC.
    Date Cleared
    2014-08-27

    (264 days)

    Product Code
    NIH
    Regulation Number
    876.5665
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    Product Code :

    NIH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Minncare HD is intended for the disinfection of water purification systems for hemodialysis. It should be diluted to a 1% concentration (1 part Minncare HD to 99 parts water) and used for a minimum contact time of 36 minutes at 20°C.
    Device Description
    Minncare HD is a clear liquid disinfectant solution that consists of a stabilized mixture of hydrogen peroxide, peracetic acid and acetic acid. Minncare HD is intended to be used for hemodialysis water purification system disinfection when diluted to a 1% concentration (1 part Minncare HD to 99 parts water) and applied for a minimum contact time of 36 minutes at 20℃. The active microbicidal ingredient is peracetic acid (PAA), and the recommended use concentration of 1%. The concentration of the use solution should be confirmed with 1% Minncare HD indicator test strips to have reached the furthest point of the distribution loop during the system disinfection contact time. Upon completion of disinfection the system must be rinsed to remove residual levels of the disinfectant. Residual levels should be checked using Minncare HD residual test strips to ensure residual levels of 1 ppm PAA or less. Minncare HD is supplied in cases containing high density polyethylene plastic bottles. Individual bottles are labeled with all information necessary to use the device safely.
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