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510(k) Data Aggregation

    K Number
    K200096
    Device Name
    Crosstex VH2O2 Chemical Indicators
    Manufacturer
    Crosstex International, Inc. (A Cantel Medical Company)
    Date Cleared
    2021-07-15

    (546 days)

    Product Code
    JOJ
    Regulation Number
    880.2800
    Why did this record match?
    Applicant Name (Manufacturer) :

    Crosstex International, Inc. (A Cantel Medical Company)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A chemical indicator for monitoring all cycles within the STERRAD® 100S (Standard & Long), 200, 100NX (Standard, Duo, Flex & Express), NX (Standard & Advanced), STERIS® V-PRO® 1 Plus (Lumen & Non-lumen), V-PRO® maX (Flexible, Lumen & Non-lumen) and Sterilucent™ PSD-85 (Lumen & Non-lumen). The VH2O2 Indicators are intended to be used by health care providers with sterilization wraps, cassettes, or pouches to distinguish between processed and unprocessed units. Colors other than blue such as yellow/green should be treated as a process failure.
    Device Description
    The Crosstex VH2O2 Chemical Indicators are intended for use as process indicators for all vaporized hydrogen peroxide cycles in the STERRAD® 100S, 200, 100NX (Standard, Duo, Flex & Express), NX (Standard & Advanced), STERIS® V-PRO® 1, V-PRO® 1 Plus, V-PRO® maX, and Sterilucent™ PSD-85 sterilization processes. The Crosstex VH2O2Chemical Indicators are intended to be used by health care providers with articles such as sterilization wraps, containers, cassettes, or pouches to distinguish between processed and unprocessed units. Chemical indicators change to a color of blue after exposure to vaporized hydrogen peroxide. Colors other than blue such as yellow/green should be treated as a process failure.
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