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510(k) Data Aggregation

    K Number
    K242642
    Device Name
    CuffTrek
    Manufacturer
    Shanghai Longmann Tech Co., Ltd.
    Date Cleared
    2025-03-07

    (185 days)

    Product Code
    BSK, DEV
    Regulation Number
    868.5750
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shanghai Longmann Tech Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CuffTrek is intended to measure and regulate the intracuff pressure of Endotracheal tubes, Tracheotomy tubes and Laryngeal Masks Airways (LMAs) (supractottic airways). The device is intended for single patient use from pediatric to adult, under medical supervision in hospitals, prehospital (EMS), extended care facilities and outpatient clinics, where a patient may be intubated. It is for disposable single patient use.
    Device Description
    The device is a battery-operated cuff pressure-controlling device intended to be used with ventilation tubes (ETT, Tracheostomy, LMA). It is a single patient-use, non-sterile device designed to be used continuously for up to 7 days. The device is connected to the pilot balloon of airways with inflatable air-filled cuffs via the device's extension line. The operating range of the device is 0-99 cmH2O. The device body houses the active pressure monitoring mechanism, which displays the cuff pressure on the digital screen. An indicator light provides an additional visual aid to indicate whether the cuff pressure is at the correct pressure or if the pressure is out of the set range of 20-30 cmH2O (red).
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