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510(k) Data Aggregation

    K Number
    K042556
    Device Name
    SHINEBALL PVC MANUAL RESUSCIATOR, ENT-1001, ENT-1003, ENT-1005, SHINEBALL SILICONE MANUAL RESUSCIATOR, ENT-1022,
    Date Cleared
    2005-03-11

    (172 days)

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

    ENTER MEDICAL CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To be used in emergency situations to provide lung ventilation to individuals whose breathing is inadequate.
    Device Description
    ShineBall manual emergency resuscitator is a portable device used in life emergency situations to provide lung ventilation to individual whose breathing is inadequate. An optional ShineBall mask is recommended for use with a resuscitator to cover the patient's nose and mouth as a port to receive the patient connector of the resuscitator. A standard reservoir bag is to be used with the ventilation bag when the oxygen gas is supplied to the patient. The performances of the manual resuscitators are intended for operator-powered types. Operator-powered resuscitator device is a device by which the ventilation of the lung is produced by operator's compressing the air out of the compressible part of the device. To reach the best effect of the clinical situations, adult, child and infant sizes of the resuscitators are designed according to body mass ranges. For safety consideration the pressure limiting valve is designed optionally for those who are not so skillful to operate the device. By adding the pressure limiting valve into the setting of the device, the pressure of the lung ventilation can be controlled easily according to patient's individual requirement. To lighten the financial burden of the patient or medical facilities, the material of Silicone, which can be autoclaved, is provided for reuse. To lower the cross-infection hazard the material PVC are used for single use and disposable ones.
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