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510(k) Data Aggregation

    K Number
    K221782
    Device Name
    Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes
    Manufacturer
    Merit Medical Pte. Ltd.
    Date Cleared
    2023-03-17

    (269 days)

    Product Code
    DRS
    Regulation Number
    870.2850
    Why did this record match?
    Applicant Name (Manufacturer) :

    Merit Medical Pte. Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Meritrans ECO Reusable Pressure Transducer is intended to be coupled with a disposable dome kit for converting hemodynamic pressure waveforms via a piezoresistive bridge circuit into electrical signals for invasive blood pressure monitoring when connected to a patient monitor or recording device. The devices are intended for pediatric and adult patient populations.
    Device Description
    The Meritrans ECO Reusable Pressure Transducer is a non-invasive, reusable device used primarily for blood pressure monitoring. The housing assembly interfaces the pressure sensor assembly to the fluid channel of patient by coupling the transducer to the Meritrans ECO Disposable Dome. The fluid channel of patient is isolated from the pressure sensor by diaphragms. As the pressure signal of patient carried via the saline solution presses against the surface of transducer, the diaphragm is deflected, and the physiological pressure signal is transformed from the dome to the sensor of the reusable pressure transducer. Subsequently, the physiological pressure signal is transformed into electrical signal and displayed in a monitor that is connected via transducer interface cable. The Meritrans ECO Disposable Domes are disposable diaphragm domes which are coupled with the reusable transducer for invasive blood pressure monitoring. The disposable diaphragm dome has a transparent hemispherical hollow cavity. The domes have two ports; one port of the dome has a rotating Luer Lock fitting where the patient line is connected. Another port has an adaptor for connection to a pressurized IV fluid bag or an infusion pump. The disposable diaphragm dome has a diaphragm membrane that isolates the patient's fluid-filled system from the reusable transducer. For dome models with flush devices, an integral flow/flush device provides continuous flow of fluid to maintain catheter patency during the invasive blood pressure measurements.
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