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510(k) Data Aggregation

    K Number
    K013401
    Device Name
    K-SYSTEMS CULTURE BAG SEALER AND CULTURE BAGS TYPE CBS-1 AND CB-01
    Date Cleared
    2001-12-14

    (60 days)

    Product Code
    Regulation Number
    884.6120
    Why did this record match?
    Applicant Name (Manufacturer) :

    K-SYSTEMS, KIVEX BIOTEC LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The K-Systems Culture bag system is intended for use during Assisted Reproduction Technology (ART). The K-SYSTEMS Culture Bag System is a device for storing culture dishes (with embryos and gametes) and to provide a stable CO2 and pH microenviroment. The K-Systems Culture Bag Sealer is a bench top device which inflates the K-Systems Culture Bags with correct gas mixture and which seals the K-Systems Culture Bags. The K-Systems Culture Bags are specially designed Culture Bags which have low penetration value for Oxygen and CO2 and which are flexible and transparent making it possible to evaluate the cells within the culture bag. When the K-Systems Culture Bags have been filled with the appropriate gas mixture the K-Systems Culture Bags are placed in a conventional incubator for maintaining the temperature. The K-Systems culture bag sytem is a closed system that reduces the risk of cross contamination within the incubator.
    Device Description
    The K-Systems Culture Bag System is a device for storing culture dishes (with embryos and gametes) and to provide a stable CO2 and pH microenvironment. The K-Systems Culture Bag Sealer is a bench top device which inflates the K-Systems Culture Bags with correct gas mixture and which seals the K-Systems Culture Bags. The K-Systems Culture Bags are specially designed Culture Bags which have low penetration value for Oxygen and CO2 and which are flexible and transparent making it possible to evaluate the cells within the culture bag.
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