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510(k) Data Aggregation

    K Number
    K092687
    Device Name
    VENTI.PLUS HYPERINFLATION BAG SYSTEM WITH PRESSURE MANOMETER
    Manufacturer
    A PLUS MEDICAL
    Date Cleared
    2009-11-23

    (83 days)

    Product Code
    NHK
    Regulation Number
    868.5905
    Why did this record match?
    Product Code :

    NHK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Single patient use non self-inflating manual resuscitator for use in hospital and transport to temporary ventilate neonate, infant and pediatric patients. The pressure manometer in this product provides a visual indication of airway pressure during ventilation.
    Device Description
    Single patient use hyperinflation bag with pressure manometer offered in 0.25, 0.50 and 1.0 liter ventilation bag sizes. End user manipulates gas flow and respiratory rate and exhalation port to control amount of gas, inspiratory pressure supplied to the patient. Each device has an integrated 0 - 60 cm H2O pressure manometer.
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    K Number
    K020281
    Device Name
    MODIFICATION TO VENTLAB HYPERINFLATION BAG SYSTEM
    Manufacturer
    VENTLAB CORP.
    Date Cleared
    2002-02-11

    (14 days)

    Product Code
    NHK
    Regulation Number
    868.5905
    Why did this record match?
    Product Code :

    NHK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ventlab Corporation's Hyperinflation Bag System is a pulmonary-assist device intended to provide assisted ventilation to patients. It is designed for patients suffering from respiratory insufficiency. The system's mode of operation is to ventilate a patient by forcing a volume of fresh gas into the patient via compression of the reservoir bag. The operating clinician controls peak pressure and monitors several respiratory parameters by use of a built-in manometer. Additional high pressures within the system may be controlled by use of the optional Pop-Off Valve.
    Device Description
    Ventlab Hyperinflation Bag System with Built-In Pressure Monitor and Optional Pop-Off Valve
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    K Number
    K013308
    Device Name
    VENTLAB HYPERINFLATION BAG SYSTEM
    Manufacturer
    VENTLAB CORP.
    Date Cleared
    2001-12-20

    (77 days)

    Product Code
    NHK
    Regulation Number
    868.5905
    Why did this record match?
    Product Code :

    NHK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ventlab Corporation's Hyperinflation Bag System is a pulmonary-assist device intended to provide controlled or assisted ventilation to patients. It is designed for patients suffering from respiratory insufficiency. The system's mode of operation is to hyper-ventilate a patient by forcing a volume of fresh gas into the patient via compression of the reservoir bag. Typical treatment consists of hyper-inflating the patient's lung(s) over several respiration cycles. The operating clinician controls peak pressure and monitors pressure in the lungs by means of a user-supplied manometer.
    Device Description
    Ventlab Corporation's Hyperinflation Bag System is a pulmonary-assist device intended to provide controlled or assisted ventilation to patients. It is designed for patients suffering from respiratory insufficiency. The system's mode of operation is to hyper-ventilate a patient by forcing a volume of fresh gas into the patient via compression of the reservoir bag. Typical treatment consists of hyper-inflating the patient's lung(s) over several respiration cycles. The operating clinician controls peak pressure and monitors pressure in the lungs by means of a user-supplied manometer.
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    K Number
    K001714
    Device Name
    MERCURY MEDICAL HYPERINFLATION BAG SYSTEM, MODEL 83-900-0149
    Manufacturer
    MERCURY MEDICAL
    Date Cleared
    2000-11-03

    (151 days)

    Product Code
    NHK
    Regulation Number
    868.5905
    Why did this record match?
    Product Code :

    NHK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K970785
    Device Name
    SIMS HYPERINFLATION BAG SYSTEM
    Manufacturer
    SIMS
    Date Cleared
    1997-06-13

    (101 days)

    Product Code
    NHK
    Regulation Number
    868.5905
    Why did this record match?
    Product Code :

    NHK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SIMS Hyperinflation Bag System is a pulmonary-assist device intended to hyper-ventilate a patient by forcing a volume of fresh gas into the patient via compression of the ventilator bag to prevent atelectasis. It is designed for patients suffering from respiratory insufficiency. Typical treatment consists of hyperinflating the patient's lung over several respiration cycles, each terminating in a preset PEEP (positive end expiratory pressure). Peak pressure is controlled by the user and monitored by means of a user-supplied manometer or optional disposable manometer.
    Device Description
    The SIMS Hyperinflation Bag System is a pulmonary-assist device intended to hyper-ventilate a patient by forcing a volume of fresh gas into the patient via compression of the ventilator bag to prevent atelectasis.
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