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    K Number
    K093913
    Device Name
    MERCURY MEDICAL T-PIECE RESUSCITATOR
    Manufacturer
    MERCURY MEDICAL, INC.
    Date Cleared
    2010-04-06

    (105 days)

    Product Code
    BTL
    Regulation Number
    868.5925
    Why did this record match?
    Applicant Name (Manufacturer) :

    MERCURY MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Neo-Tee™ T-Piece Resuscitator is a gas powered emergency resuscitator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway. It is intended for use with neonates and infants weighing less than 10kg (22 lb).
    Device Description
    The Mercury Medical T-Piece Resuscitator (Neo-Tee™) is a gas power resuscitator for use with neonates / infants < 10 kg (22 lb). It is a simple T-piece, with a manometer and the ability to adjust Peak Inspiratory Pressure (PIP) and Positive End-Expiratory Pressure (PEEP). It incorporates a pressure relief valve for excessive pressure. The Mercury Medical T-Piece Resuscitator (Neo-Tee™) can be connected to the patient via a face mask or endotracheal tube.
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