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510(k) Data Aggregation

    K Number
    K133267
    Device Name
    DANA REUSABLE TEST PACK
    Manufacturer
    DANA PRODUCTS, INC.
    Date Cleared
    2014-02-11

    (110 days)

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

    DANA PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dana Reusable Test Pack is designed to challenge steam sterilization process in healthcare facilities. It is intended to be used for routine monitoring of pre-vacuum steam sterilization cycles. It is validated to be used in 4 minute 270°F pre-vacuum steam sterilization cycles with a 3M TM Attest ™ Super Rapid Readout Biological Indicator 1492V along with or without SteriScan Integrators.
    Device Description
    Not Found
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    K Number
    K130135
    Device Name
    DANA REUSABLE BI TEST PACK
    Manufacturer
    DANA PRODUCTS, INC.
    Date Cleared
    2013-11-25

    (311 days)

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

    DANA PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dana Reusable Test Pack is designed to challenge steam sterilization process in healthcare facilities. It is intended to be used for routine monitoring of pre-vacuum steam sterilization cycles. It is validated to be used in 4 minute 270°F pre-vacuum steam sterilization cycles with SGM Biotech's Self-Contained Biological Indicator Smart-Read EZTest - Steam along with or without SteriScan Integrators.
    Device Description
    Not Found
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    K Number
    K120592
    Device Name
    DANA REUSABLE BOWIE TEST PACK FOR DANA BOWIE DICK INDICATORS
    Manufacturer
    DANA PRODUCTS, INC.
    Date Cleared
    2013-02-27

    (365 days)

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

    DANA PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dana Reusable Bowie Dick Type Test Pack, when used with a Dana Bowie Dick indicator, is designed for testing the air removal efficiency of pre-vacuum steam sterilizers. The indicator will demonstrate complete dye migration when proper sterilization conditions are met and proper vacuum is achieved. If there is inadequate vacuum such that would result in a 2°C (+1°-0°C) temperature difference between the center of the ANSVAAMI/ISO 11140-5:2007 Standard Test Pack and the drain temperature at the beginning of the final minute of a three and a half minute cycle, the indicator will demonstrate incomplete dye migration (incomplete color change in the indicator window). The test parameters used for validating this device were 134℃ for 3.5 minutes with a 2 minute dry time.
    Device Description
    Dana Reusable Bowie Dick Type Pack and Dana Bowie Dick Indicators
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    K Number
    K110253
    Device Name
    REUSABLE TEST PACK FOR DANA EMULATING INDICATORS
    Manufacturer
    DANA PRODUCTS, INC.
    Date Cleared
    2011-04-29

    (91 days)

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

    DANA PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dana Reusable Test Pack is designed to challenge steam sterilization process in healthcare facilities. It is intended to be used for routine monitoring of pre-vacuum steam sterilization cycles. It is validated to be used in 4 minute 270°F pre-vacuum 4 minute steam sterilization cycles with the Dana Emulating Indicator cleared by FDA under K100891.
    Device Description
    Reusable Integrator Test Pack for Dana Emulating Indicator.
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    K Number
    K103321
    Device Name
    DANA REUSABLE TESTPACK FOR STEAM STERILIZATION FOR 10 MINUTE EXTENDED CYCLES
    Manufacturer
    DANA PRODUCTS, INC.
    Date Cleared
    2011-02-16

    (96 days)

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

    DANA PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The disposable polypropylene sleeve assembly with 3M's 1292 Bl used with the Dana Reusable Test Pack can be used for routine monitoring of 10 Minute 270° F pre-vacuum steam sterilization cycles. The polypropylene sleeve assembly is intended to be used only with Dana Reusable Test Pack cleared under K 092944.
    Device Description
    Reusable Biological Indicator Test Pack for Steam Sterilization.
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    K Number
    K100891
    Device Name
    DANA EMULATING INDICATOR
    Manufacturer
    DANA PRODUCTS, INC.
    Date Cleared
    2011-01-13

    (288 days)

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

    DANA PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dana Emulating Indicator is for use in 4 minute 270°F (132°C) pre-vacuum steam sterilization process. When exposed to steam sterilization temperature and time the dark bar will travel along the window and enter the accept area giving an indication that steam sterilization conditions were met. Critical Parameters in a standard hospital pre-vacuum steam sterilizer Temperature : 270°F (132°C) Time: 4 Minutes
    Device Description
    Not Found
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    K Number
    K102761
    Device Name
    DANA REUSABLE TEST PACK FOR STEAM STERILIZATION
    Manufacturer
    DANA PRODUCTS, INC.
    Date Cleared
    2010-12-20

    (88 days)

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

    DANA PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dana reusable challenge test pack is designed to challenge steam sterilization process in healthcare facilities. It is intended to be used for routine monitoring of pre-vacuum steam sterilization cycles. It is validated to be used in 4 minute 270°F pre-vacuum steam sterilization cycles with SteriScan Integrators.
    Device Description
    Reusable SteriScan Integrator Test Pack for Steam
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    K Number
    K092944
    Device Name
    DANA REUSABLE TEST PACK FOR STEAM STERILIZATION
    Manufacturer
    DANA PRODUCTS, INC.
    Date Cleared
    2010-03-18

    (175 days)

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

    DANA PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dana reusable test pack is designed to challenge steam sterilization process in healthcare facilities. It is intended to be used for routine monitoring of pre-vacuum steam sterilization cycles. It is validated to be used in 4 minute 270°F pre-vacuum steam sterilization cycles with 3M's 1292 Rapid Readout Biological Indicators along with or without SteriScan Integrators.
    Device Description
    Reusable Biological Indicator and Integrator Test Pack for Steam Sterilization.
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    K Number
    K012195
    Device Name
    STEAM STERILIZATION INTERGRATOR
    Manufacturer
    DANA PRODUCTS, INC.
    Date Cleared
    2002-05-07

    (298 days)

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

    DANA PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dana Steam Sterilization Integrators are intended to monitor critical parameters in steam sterilization cycles in healthcare facilities. The critical parameters for which the integrators will respond are time and temperature (when steam is present). The end point is determined by the migration of the steam sensitive dye to an area marked safe on the indicator. The integrators are intended to be used in 30 minute gravity cycles at 250 degrees F and 3 minute gravity and pre- vacuum cycles at 270 degrees F.
    Device Description
    Not Found
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