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510(k) Data Aggregation

    K Number
    K031431
    Device Name
    BAWMED RESCUE MASK
    Manufacturer
    BAWMED UK
    Date Cleared
    2004-07-13

    (434 days)

    Product Code
    CBP
    Regulation Number
    868.5870
    Why did this record match?
    Applicant Name (Manufacturer) :

    BAWMED UK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Bawmed UK Bawmed EZ-Mask Air Pulmonary Resuscitator is indicated for mouth to mask ventilation of a non-breathing adult and child weighing over 30 kgs.
    Device Description
    Bawmed Rescue Mask (also referred to as Bawmed EZ-Mask)
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    K Number
    K031434
    Device Name
    BAWMED E-Z BAG RESUSCITATOR
    Manufacturer
    BAWMED UK
    Date Cleared
    2004-02-06

    (276 days)

    Product Code
    BTM
    Regulation Number
    868.5915
    Why did this record match?
    Applicant Name (Manufacturer) :

    BAWMED UK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Bawmed E-Z Bag Resuscitators are manual resuscitators incorporating a bag and valve, intended to provide respiratory support to patients suffering from respiratory distress. The infant model is intended for patients weighing between 5 to 12 kgs, the child model is intended for patients weighing between 10 to 30 kgs, and the adult model is intended for patients weighing more than 30 kgs approximate weight. The Bawmed E-Z Bag Resuscitator provided in reusable models and in the disposable models.
    Device Description
    manual resuscitators incorporating a bag and valve
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