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510(k) Data Aggregation

    K Number
    K220854
    Device Name
    TrachCuff Cuff Controller
    Manufacturer
    AW Technologies ApS
    Date Cleared
    2023-04-14

    (387 days)

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

    AW Technologies ApS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TrachCuff Cuff Controller is intended to continuously measure and automatically maintain the user-set cuff pressure of an endotracheal tube (ETT) or tracheostomy tube (TT) during mechanical ventilation. The TrachCuff Cuff Controller can be used with any mechanical ventilator. The TrachCuff Cuff Controller is to be used during ventilation of adults at least 18 years who are intubated with ETT or TT, in the following areas: - In the intensive care ward by Respiratory Therapist Prescription use only.
    Device Description
    The TrachCuff Cuff Controller is an automatic cuff pressure controller specified for use in professional healthcare environments. The device provides the operator with the means to set and control the pressure for cuffed endotracheal tubes and cuffed tracheostomy tubes during mechanical ventilation, and continuous monitoring of the set cuff pressure with alarms. The TrachCuff Cuff Controller is mains powered via a Mains to DC power adapter, and the enclosure may be mounted on a bed rail by means of an optional mounting bracket. The TrachCuff Cuff Controller is provided in an enclosure with touch screen operator panel. It is designed for immediate use; no calibration or maintenance is required. A largescale display and convenient and intuitive interaction buttons maximize safe use and visibility of all important data. The associated accessories include: - Disposable Tubing Set with Filter . - Device Mount Solution Bedside Mounting Bracket. .
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