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    K Number
    K240847
    Device Name
    MedicCO2LON (MedicCO2LON)
    Manufacturer
    IDE Vision Ltd
    Date Cleared
    2024-10-30

    (217 days)

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

    IDE Vision Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MedicCO2LON device is intended to be used for colonic distension with CO2 gas for CT Colonography and conventional Colonoscopy procedures. MedicCO2LON is designed to function with specific colonic insufflation administration sets that allow passage of gas from the device to the colorectal cavity. MedicCO2LON should only be used with administration sets specifically designed for this purpose. The device should only be used by personnel trained in the practice of undertaking CT Colonography and conventional Colonoscopy examinations and the use of an automatic insufflation device. The device should only be used for CT Colonography or conventional Colonoscopy procedures and should not be used for any other patient examination procedure.
    Device Description
    MedicCO2LON is an automated insufflation device designed for administering and requlating colonic distension by insufflation with carbon dioxide qas, in preparation for and during CT Colonography (CTC or Virtual Colonoscopy) and conventional Colonoscopy. Construction: The MedicCO2LON colonic insufflator is constructed using a plastic (PC/ABS) external shell covering a metal internal frame, internal components are low voltage (3.3V, 12V and 24V DC) powered from an internal mains connected power supply. None of the parts of the MedicCO2LON contact the patient directly and the user only has transient contact with the unit, with it being table or trolley mounted. Use period: The units are for short term use (normally no more than 30 min) and provides. to the patient, CO2 via an external pressure regulator to the device to insufflate the patient using a standard administration set at up to 30mmHg
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