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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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    K Number
    K111343
    Device Name
    CROSSTEX ISOFLUID PLUS SURGICAL EARLOOP MASK-BLUE, CROSSTEX ISOFLUID PLUS FOGFREE SURGICAL EARLOOP FACE MASK-BLUE, CROSS
    Manufacturer
    CROSSTEX INTERNATIONAL, INC.
    Date Cleared
    2011-10-06

    (146 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Why did this record match?
    Applicant Name (Manufacturer) :

    CROSSTEX INTERNATIONAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The following Crosstex® Isofluid Plus Surgical Masks are intended for use in infection control practices to minimize contamination caused by inhaled and exhaled microorganisms and reduce the potential exposure of the wearer to blood and body fluids. (non-sterile) - Crosstex® Isofluid Plus Surgical Earloop Face Mask Blue . - Crosstex® Isofluid Plus FogFree Surgical Earloop Face Mask Blue . - Crosstex® Isofluid Plus FogFree Surgical Earloop Face Mask with Splash Visor Blue .
    Device Description
    The Crosstex Isofluid Plus Surgical Masks are constructed of a cellulose inner facing, a 100% Spundonded porypropyitent elastic loops. The nose piece for the polypropyiene inter firedia, with non facil cae no fog strip (if applicable) is made of melt blow polypropylene.
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    K Number
    K103303
    Device Name
    CROSSTEX SURGICAL EARLOOP MASK- WHITE, CROSSTEX SURGICAL EARLOOP NO FOG MASK-WHITE, NO FOG MASK WITH SPLASH VISOR-WHITE
    Manufacturer
    CROSSTEX INTERNATIONAL, INC.
    Date Cleared
    2010-12-23

    (44 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Why did this record match?
    Applicant Name (Manufacturer) :

    CROSSTEX INTERNATIONAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The following Crosstex® Surgical Masks are intended for use in infection control practices to minimize contamination caused by inhaled and exhaled microorganisms and reduce the potential exposure of the wearer to blood and body fluids. - Crosstex® Surgical Earloop Mask White ● - Crosstex® Surgical Earloop No Fog Mask White . - Crosstex® Surgical Earloop No Fog Mask with Splash Visor White .
    Device Description
    The Crosstex Surgical Masks are constructed of a cellulose inner facing, a 100% spunbonded polypropylene white outer facing, a 100% meltblown polypropylene filter media, with white non-latex elastic loops. The nose piece for the Crosstex Surgical Masks is aluminum wire while the no fog strip (if applicable) is made of melt blow polypropylene.
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