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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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