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    K Number
    K193250
    Device Name
    Irrigation Tubing with CO2 or Air
    Manufacturer
    KeyMed (Medical and Industrial Equipment) Ltd.
    Date Cleared
    2020-04-06

    (133 days)

    Product Code
    OCX
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    KeyMed (Medical and Industrial Equipment) Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Irrigation Tubing with CO2 or Air is intended for use up to 24 hours, to provide sterile water for irrigation through the auxiliary channel (via an irrigation flushing pump when used with an Auxiliary Channel Adaptor) and CO2 or ar insufflation and lens flushing through the dual air-water channel (via a CO2 Gas Insufflator or Air pump supply) of compatible gastrointestinal/colono-endoscopes.
    Device Description
    The proposed device consists of four separate labelled tube set devices in total, two tube sets (MAJ-2207 & MAJ-2208) designed to be used with CO2 with differing bottle cap thread variants: and two tube sets (MAJ-2209 & MAJ-2210) designed to be used with Air with differing bottle cap thread variants to fit a variety of on the market branded disposable sterile bottles.
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