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510(k) Data Aggregation

    K Number
    K170329
    Device Name
    Basic, Dominant Flex
    Manufacturer
    Modela AG
    Date Cleared
    2017-03-24

    (50 days)

    Product Code
    QPB, BTA, HDB, MUU
    Regulation Number
    878.5040
    Why did this record match?
    Applicant Name (Manufacturer) :

    Modela AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use for Medela's Basic and Dominant Flex Suction Pumps is to provide a vacuum source for use in hospitals and clinics. Basic: The intended use of the Basic suction pump is the creation of a constant vacuum for use in hospitals and clinics. This vacuum can be used for general suction, to aspirate and remove: surgical fluids, tissue (including bone), gases, bodily fluids or infectious materials and during specific procedures which may include, vacuum extraction, aspiration during flexible endoscopy, use with cardiac tissue stabilizers during off-pump coronary artery bypass and epicardial ablation probes. Dominant Flex: The intended use of the Dominant Flex suction pump is the creation of a constant vacuum for use in hospitals and clinics. This vacuum can be used for general suction, to aspirate and remove: surgical fluids, tissue (including bone), gases, bodily fluids or infectious materials and during specific procedures which may include, vacuum extraction, aesthetic body contouring, aspiration during flexible endoscopy, use with cardiac tissue stabilizers during off-pump coronary artery bypass, and epicardial ablation probes.
    Device Description
    The Medela" Basic and Dominant Flex are high vacuum and high flow, AC-powered suction pumps that can be used when large quantities of fluid must be suctioned quickly in the hospital, ambulatory surgery center, clinic, and doctors' practice. Their construction includes a piston and cylinder system which provides strong suction performance and quiet, dependable operation and a microcontroller which is used to control motor speed and the user interface. Additional advantages of the Medela" Basic and Dominant Flex are user friendliness and simple cleaning. Medela® Basic and Dominant Flex cover the 4 main functions of - . Powerful and high suction capacity - . Rapid vacuum build-up - Low vibrations and quiet - . Design; smooth surface and easy to use and clean The Medela" Basic provides a fixed airflow of 30 l/m and the Medela" Dominant Flex offers the innovative function of selectable airflow of 40, 50 or 60 l/m. All operating elements for nurses or doctors are located on the front side of both pumps. These include the vacuum gauge, vacuum regulator knob, operating elements and Safety Set. The Safety Set consists of a 0.25l jar, lid and float and prevents an overflow into the pump. The Medela" Basic and Dominant Flex suction pumps can be operated via capacitive sensors (called "CleanTouch") to turn the pumps on/off. Additionally the Dominant Flex has capacitive sensors for adjusting the flow between 40, 50 and 60 l/m. Both pumps have a knob for the vacuum regulator. The vacuum inside the tubing is displayed on the vacuum gauge. The Medela" Basic and Dominant Flex use three indicator lights to provide information to the user on the status of the pump. All operating elements for the biomedical technicians are located on the back side. This is where the appliance inlet for plugging in the power cord is located. Both pumps are available either as rack or portable version can be combined with the trolley to create a mobile version. A variety of reusable and disposable accessories are available for use with the Medela" Basic and Dominant Flex suction pumps or are intended to be marketed with these pumps.
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