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510(k) Data Aggregation

    K Number
    K971759
    Device Name
    MEDPORT EMERGENCY MEDICATION AIRWAY TUBE ADAPTER
    Manufacturer
    GREEN FIELD MEDICAL SOURCING, INC.
    Date Cleared
    1998-03-02

    (294 days)

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

    GREEN FIELD MEDICAL SOURCING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - 1. To establish a path in which to inject medication into the lungs of a patient who has undergone cardiac and/or pulmonary arrest and who is being ventilated through an intubated airway. - 2. To establish a means in which to introduced medication into an intubated airway without interrupting the flow of life-supporting ventilation to the patient. - 3. To provide an alternative means other than intravenous injection for administering lifesaving drugs when a patient is being assisted by an endotracheal ube.
    Device Description
    Not Found
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    K Number
    K971348
    Device Name
    FASTTRACH SINGLE-PASS TRACHEAL/ESOPHAGEAL AIRWAY SYSTEM
    Manufacturer
    GREEN FIELD MEDICAL SOURCING, INC.
    Date Cleared
    1998-02-27

    (323 days)

    Product Code
    CAO
    Regulation Number
    868.5650
    Why did this record match?
    Applicant Name (Manufacturer) :

    GREEN FIELD MEDICAL SOURCING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - 1. To establish a patent airway to provide ventilation to a patient who has undergone cardiac* and/or pulmonary arrest. - 2. To establish a protected airway where a compromised or obstructed airway exists in an unconscious patient. * - To establish a patent airway in a conscious patient who is unable to ventilate 3. adequately. * - 4. To establish a patent airway where a rescuer is unable to ventilate the unconscious patient with conventional methods. * - 5. This device is particularly indicated where standard tracheal tube intubation may be difficult or not possible. - 6. Where either tracheal or esophageal obturator airway is indicated. - 7. Applicable to larger children, small adult or adult depending on sizes of our product available, with applied clinical judgement required. - 8. For use by a person trained and experienced in airway management and the use of this device.
    Device Description
    FastTrach Single-Pass Trachea1/Esophagea1 Airway System
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