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510(k) Data Aggregation

    K Number
    K250172
    Device Name
    Green Card Bowie-Dick Test (BD115)
    Manufacturer
    SteriTec Products, Inc. (a Getinge Company)
    Date Cleared
    2025-02-20

    (30 days)

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

    SteriTec Products, Inc. (a Getinge Company)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Green Card Bowie-Dick Test is designed to detect the presence of residual air in pre-vacuum steam sterilizers operating at 270°F (132°C) and 273°F (134°C) for 3.5 minutes. The indicator will demonstrate a uniform color change from purple to green when the proper sterilization conditions are met and no air is present. If enough air is present to create a 2°C or greater temperature difference in a standard Bowie-Dick test towel pack, the indicator will demonstrate a non-uniform color change.
    Device Description
    The Green Card Bowie-Dick Test is designed specifically for daily monitoring of pre-vacuum steam sterilizers to detect the presence of residual air as recommended by ANSI/AAMI ST79: Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities. The Green Card Bowie-Dick Test is a 3.5" X 1.91" card with the indicator ink printed on one side. Both sides of the card are laminated with a polyester film and an identification/record label is placed on the back side. The Green Card Bowie-Dick Test duplicates the resistance of a Bowie-Dick towel pack as described in ANSI/AAMI ST8 Hospital Steam Sterilizers. The Green Card Bowie-Dick Test indicator areas will uniformly change color from purple to green when a passing Bowie-Dick test is performed. If a significant amount of air is present inside the sterilizer chamber during the sterilization cycle, it will be detected by the Green Card and displayed as a purple area on the indicator card, whereas the remainder of the indicator will have turned green. The non-uniform color change demonstrates the presence of air that would have created a 2°C temperature depression in a standard cloth Bowie-Dick pack.
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    K Number
    K083650
    Device Name
    EMU-GRAPH 4 EMULATOR, MODEL CI 144
    Manufacturer
    STERITEC PRODUCTS, INC.
    Date Cleared
    2009-03-05

    (86 days)

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

    STERITEC PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SteriTec Emu-Graph 4 is a steam sterilization emulator for use in a pre-vacuum steam sterilization process operating at 132°C (270° F) or 135° C (275° F). When exposed to steam sterilization conditions the indicator bar will turn from purple to green giving an integrated response and visible indication that sterilization conditions were met. Critical Parameters in a standard hospital pre-vacuum steam sterilizer | Temperature | Time | |---------------|-----------| | 132°C (270°F) | 4 minutes | | 135°C (275°F) | 3 minutes |
    Device Description
    Not Found
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    K Number
    K080136
    Device Name
    INSTANT READOUT CHEMICAL INTEGRATOR CHALLENGE PACK, MODEL LT- 105
    Manufacturer
    STERITEC PRODUCTS, INC.
    Date Cleared
    2008-08-15

    (206 days)

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

    STERITEC PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SteriTec Instant Readout Chemical Integrator Chailenge Pack is a steam sterilization process challenge device that meets the FDA Chemical Indicator Guidelines performance requirements for chemical integrator test packs. The Integrator Challenge Pack monitors pre-vacuum steam sterilizers operating at 132°C (270°F) or 135°C (275°F). When exposed to steam sterilization conditions the Instant Readout Chemical Integrator card gives an integrated response by changing from purple to green. The integrator card inside the test pack also meets emulator performance standards according to ISO 11140-1:2005.
    Device Description
    Not Found
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    K Number
    K052516
    Device Name
    STERITEC CONTAINER CORD - CI 135, STERITEC PROCESS INDICATOR LABELS - CI 140, STERITEC PROCESS INDICATOR DOTS - CI 137
    Manufacturer
    STERITEC PRODUCTS, INC.
    Date Cleared
    2005-10-03

    (19 days)

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

    STERITEC PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SteriTec Process Indicator Container Cards, Labels, and DOTS are intended for use by health care providers with steam sterilization wraps, container, cassettes, or pouches to distinguish between processed and unprocessed items. The Cards, Labels, and DOTS can be used in 121° C gravity steam sterilizers or 132° – 134° C pre-vacuum steam sterilizers. Indicators turn to dark gray/black after exposure to steam sterilization processes.
    Device Description
    Not Found
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    K Number
    K040901
    Device Name
    STERITEC EMU-GRAPH, MODEL NO. CI 131/US
    Manufacturer
    STERITEC PRODUCTS, INC.
    Date Cleared
    2004-09-09

    (155 days)

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

    STERITEC PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SteriTec Integraph-E is a steam sterilization integrator for use in a pre-vacuum steam sterilization process at 132°C (270° F) for 2 minutes or 4 minutes. When exposed to steam sterilization conditions Integraph-E strips give an integrated response and visible indication that sterilization were met by changing from a purple to green color.
    Device Description
    SteriTec Integraph-E is a steam sterilization integrator. When exposed to steam sterilization conditions Integraph-E strips give an integrated response and visible indication that sterilization were met by changing from a purple to green color.
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    K Number
    K024293
    Device Name
    BOWIE-DICK MINI PAK, MODEL BD 115
    Manufacturer
    STERITEC PRODUCTS, INC.
    Date Cleared
    2003-08-11

    (230 days)

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

    STERITEC PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SteriTec Bowie-Dick Mini Pak is designed to detect the presence of residual air in pre-vacuum steam sterilizers operating at 132° C for 3.5 minutes. The indicator will demonstrate a uniform color change from purple to green when the proper sterilization conditions are met and no air is present. If enough air is present to create a 2° C or greater temperature difference in a standard Bowie-Dick test towel pack, the indicator will demonstrate a non-uniform color change.
    Device Description
    Not Found
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    K Number
    K012732
    Device Name
    INTEGRAPH FLASH, MODEL CI 110
    Manufacturer
    STERITEC PRODUCTS, INC.
    Date Cleared
    2002-03-04

    (200 days)

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

    STERITEC PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SteriTec Integraph Flash is a steam sterilization integrator for use in either a pre-vacuum or gravity displacement steam sterilization process of 3 minutes or longer at 132° C (270° F), or a flash steam sterilization process for a 3 Minute cycle or 10 Minute cycle in gravity displacement sterilizers. When exposed to steam sterilization conditions the Integraph Flash strips give an integrated response and visible indication that sterilization conditions were met by changing from a purple to a green color. The stated value in a laboratory test sterilizer for the 3-Minute indicator spot is 5 minutes at 132° C, and for the 10-Minute indicator spot is 11.5 minutes at 132° C.
    Device Description
    Not Found
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    K Number
    K010534
    Device Name
    CROSS-CHECKS DUAL, MODEL CI 125
    Manufacturer
    STERITEC PRODUCTS, INC.
    Date Cleared
    2001-08-06

    (164 days)

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

    STERITEC PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K003533
    Device Name
    CROSS-CHECKS LF, MODEL CI 119/S &CI 119/L
    Manufacturer
    STERITEC PRODUCTS, INC.
    Date Cleared
    2001-02-07

    (83 days)

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

    STERITEC PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K003002
    Device Name
    STERILIZATION PROCESS INDICATOR TAPES MODEL CI112 & CI123
    Manufacturer
    STERITEC PRODUCTS, INC.
    Date Cleared
    2000-12-08

    (73 days)

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

    STERITEC PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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