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510(k) Data Aggregation

    K Number
    K090777
    Device Name
    EZC MEDICAL, LLC INTUBAIDFLEX
    Manufacturer
    EZC MEDICAL, LLC
    Date Cleared
    2009-08-04

    (134 days)

    Product Code
    BTR
    Regulation Number
    868.5730
    Why did this record match?
    Applicant Name (Manufacturer) :

    EZC MEDICAL, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IntubaidFlex" is intended for use as an aid in the placement of an Endotracheal Tube (ETT) directly or through an Intubating Laryngeal Mask Airway (LMA) during non difficult and difficult intubation procedures. The IntubaidFlex achieves its purpose by providing the user with a visual confirmation of where the tip of the device is in the human anatomy. The flexible tip of the IntubaidFlex allows the user to guide the ETT in the desired direction.
    Device Description
    The IntubaidFlex" is a simple, disposable, single-patient use, sterile, handheld, portable stylet with a built in camera, that fits within an Endotracheal tube (ETT) directly or through an Intubating Laryngeal Mask Airway(LMA) and provides for video-assisted visualization of the laryngeal inlet. The IntubaidFlex" can plug into any TV monitor, hand held monitor or PC (via USB) for live video visualization.
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