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510(k) Data Aggregation

    K Number
    K132372
    Device Name
    STERITEC GREEN CARD PACK BOWIE-DICK TEST
    Manufacturer
    STERITEC PRODUCTS MFG. CO., INC.
    Date Cleared
    2013-11-26

    (119 days)

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

    STERITEC PRODUCTS MFG. CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SteriTec Green Card Pack Bowie-Dick Test is a single designed to detect the presence of residusl air in pro-veauum steam sterilizers operating at 132°C for 3.5 minutes. The indicator card within the Green Card Pack will demonstrate a uniform color change from purple to green when proper sterlization conditions are met and no air is present to create a 2° C (+19-0° C) temperature difference between the center of the towel pack, as identified in ANSVAAMI/ISO 11140-5, and the drain temperature at the beginning of the final one minute of a three and half minute cycle the indicator card within the Green Card Pack will demonstrate a non-uniform color change.
    Device Description
    Not Found
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    K Number
    K122945
    Device Name
    STERITEC GREEN CARD PACK BOWIE-DICK TEST MODEL BD 126
    Manufacturer
    STERITEC PRODUCTS MFG. CO., INC.
    Date Cleared
    2013-04-30

    (218 days)

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

    STERITEC PRODUCTS MFG. CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SteriTec Green Card Pack Bowie-Dick Test is designed to detect the presence of residual air in pre-vacuum steam sterilizers operating at 132°C for 3.5 minutes. The indicator card within the Green Card Pack will demonstrate a uniform color change from purple to green when proper sterilization conditions are met and no air is present. If enough air is present to create a 2° C (+1°-0° C) temperature difference between the center of the towel pack, as identified in ANSI/AAMI/ISO 11140-5, and the drain temperature at the beginning of the final one minute of a three and half minute cycle the indicator card within the Green Card Pack will demonstrate a non-uniform color change.
    Device Description
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    K Number
    K122555
    Device Name
    STERITEC LEAD FREE STERILIZATION PROCESS INDICATOR TAPE
    Manufacturer
    STERITEC PRODUCTS MFG. CO., INC.
    Date Cleared
    2012-12-12

    (112 days)

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

    STERITEC PRODUCTS MFG. CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SteriTec Green Tape can be used in 121°C gravity sterilizers for 30 minutes or pre-vacuum sterilizers operating at 132°C for 4 minutes and 135°C for 3 minutes. Stripes turn black after exposure to steam sterlization conditions, thus providing identification of processed items.
    Device Description
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    K Number
    K111150
    Device Name
    STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR
    Manufacturer
    STERITEC PRODUCTS MFG. CO., INC.
    Date Cleared
    2011-07-08

    (74 days)

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

    STERITEC PRODUCTS MFG. CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SteriTec Smart Read Biological Test Pack with Instant Readout Integrator is designed specifically for testing of 3 or 4 minutes at 132°C (270°F) and 3 minutes at 135°C (275°F) in pre-vacuum steam sterilizers. When used as directed, the Chemical Indicator Record Card gives visible indication that sterilizing conditions were met.
    Device Description
    The test pack consists of a self-contained biological indicator containing Geobacillus stearothermophilus inside a small package of porous and nonporous materials, simulating the biological indicator 16 towel test packs defined by AAMI ST79.
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    K Number
    K103000
    Device Name
    SMART READ BIOLOGICAL TEST PACK
    Manufacturer
    STERITEC PRODUCTS MFG. CO., INC.
    Date Cleared
    2011-02-11

    (126 days)

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

    STERITEC PRODUCTS MFG. CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SteriTec Smart-Read® Biological Test Pack with Instant Readout Integrator is designed specifically for testing of 3 minutes or longer at 132°C (270°F) in pre-vacuum steam sterilizers. The test pack consists of a self-contained biological indicator containing Geobacillus stearothermophilus inside a small package of porous and nonporous materials, simulating the biological indicator 16 towel test packs defined by ANSI/AAMI ST79. When used as directed, the Chemical Integrator Record Card gives visible indication that sterilizing conditions were met.
    Device Description
    The test pack consists of a self-contained biological indicator containing Geobacillus stearothermophilus inside a small package of porous and nonporous materials, simulating the biological indicator 16 towel test packs defined by ANSI/AAMI ST79. When used as directed, the Chemical Integrator Record Card gives visible indication that sterilizing conditions were met.
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    K Number
    K072408
    Device Name
    EMU-GRAPH EMULATOR, MODEL CI 131
    Manufacturer
    STERITEC PRODUCTS MFG. CO., INC.
    Date Cleared
    2008-04-30

    (247 days)

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

    STERITEC PRODUCTS MFG. CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SteriTec Emu-Graph is a steam sterilization emulator for use in a pre-vacuum steam sterilizer at 132°C (270° F) or 135° C (275° F). When exposed to a steam sterilization process, the 2 MIN and 4 MIN indicator bars will turn from purple to green giving an integrated response and visible indication that sterilization conditions were met. If only the 2 MIN indicator bar turns green and the 4 MIN indicator bar displays an incomplete color change, insufficient sterilization conditions occurred. Critical Parameters in a standard hospital pre-vacuum steam sterilizer | Temperature | 4 MIN Indicator | |---------------|-----------------| | 132°C (270°F) | 4 minutes | | 135°C (275°F) | 3 minutes |
    Device Description
    Not Found
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    K Number
    K000502
    Device Name
    STEAM/EO RECORD CARD, MODEL CI 121
    Manufacturer
    STERITEC PRODUCTS MFG. CO., INC.
    Date Cleared
    2000-03-14

    (28 days)

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

    STERITEC PRODUCTS MFG. CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K990246
    Device Name
    STERI-PAK LF BOWIE-DICK TEST PACK
    Manufacturer
    STERITEC PRODUCTS MFG. CO., INC.
    Date Cleared
    1999-06-10

    (135 days)

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

    STERITEC PRODUCTS MFG. CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Steri-Pak LF Bowie Dick Test Pack manufactured by SteriTec Products Mfg. Co., Inc. is designed to detect the presence of residual air in prevacuum steam sterilizers operating at 132 °C. It is designed to be used for daily Bowie Dick testing of hospital sterilizers as described in AAMI/ANSI ST46 section 7.7. It contains no Lead.
    Device Description
    The Steri-Pak LF Bowie-Dick Test Pack is designed specifically for daily monitoring of pre-vacuum steam sterilizers to detect the presence of residual air. The test pack is approximately 3%" x 5/4" x2/" in size consisting of a stack of 25 layers of porous blotter paper with a plastic laminated layer at the bottom. Embedded within the pack is an indicator sheet with steam sensitive ink printed on it. The indicator sheet changes to black during a typical Bowie-Dick test and will have a lighter, blue color in the center if a significant amount of air is present during the test.
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    K Number
    K982188
    Device Name
    STERI-PAK BOWIE DICK TEST PACK
    Manufacturer
    STERITEC PRODUCTS MFG. CO., INC.
    Date Cleared
    1998-11-20

    (151 days)

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

    STERITEC PRODUCTS MFG. CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K981497
    Device Name
    STERITEC DISPOSABLE BIOLOGICAL TEST PACK-EO GAS
    Manufacturer
    STERITEC PRODUCTS MFG. CO., INC.
    Date Cleared
    1998-10-29

    (185 days)

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

    STERITEC PRODUCTS MFG. CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Steritec Disposable EO Biological Test Pack is designed specifically for biological testing of EO gas sterilizers. The performance specifications for this product are 130 F, 45% to 60% Relative Humidity, 600 mg/L EO gas with all survivors at 15 minutes and all killed at 60 minutes.
    Device Description
    SteriTec Disposable Biological Test Packs for EO Gas consist of a self-contained biological indicator containing B. Subtillis spores, placed inside a plastic canister and is covered with a closure cap containing a 5-100 micron porous plastic filter. This assembly is placed into a paper/plastic peel pouch along with a printed record card containing a chemical indicator.
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