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510(k) Data Aggregation

    K Number
    K112754
    Device Name
    IVENT101
    Manufacturer
    VERSAMED MEDICAL SYSTEMS LTD.
    Date Cleared
    2012-06-15

    (268 days)

    Product Code
    CBK, IVE, NOU
    Regulation Number
    868.5895
    Why did this record match?
    Applicant Name (Manufacturer) :

    VERSAMED MEDICAL SYSTEMS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The iVent101 ventilator [with single or dual limb configuration] is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for infants from 5 kg through adult patients who require invasive or non-invasive support via the following ventilatory modalities: - Assist/Control and SIMV with either Volume, Pressure Regulated Volume . Control (PRVC) - CPAP with Pressure Support and CPAP / Pressure Support Volume Guaranteed (VG) ● - Adaptive Bi-Level for either NIV or invasive ventilation and Adaptive Bi-Level Volume ● Guaranteed [VG] The iVent101 ventilator is suitable for use in institution, home and portable settings
    Device Description
    The iVent101 is a compact, portable, microprocessor-controlled ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. A turbine-powered air source and a rechargeable internal battery provide freedom from wall air and power outlets. Internal flow and pressure are read through low/pressure sensors. Clinical data [Tidal Volume, Rate, PIP, FiO2, Peak Flow, Inspiratory Time, I:E Minute Volume) are presented on machine screen. All the operator actions are performed on the LCD touch-screen on the front panel, allowing rapid control and continuous real-time monitoring of patient ventilation. Alarm settings are fully adjustable. Optional Waveform and Diagnostic Software package displays pressure and flow waveform data, loops, trends, and logged totals in a full array of time slices and presentation modes. The iVent101 can use external AC or DC power supply and contains an integrated battery. The iVent101 is equipped with two configurations, which differs in the patient circuit type that connects to the machine. One configuration is to be used with a standard one limb patient circuit, and the second configuration is to be used with a standard dual limb patient circuit. The two configurations are incorporating the same infrastructure and can be easily replaced by the user.
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    K Number
    K092135
    Device Name
    MODIFICATION TO IVENT 101
    Manufacturer
    VERSAMED MEDICAL SYSTEMS LTD.
    Date Cleared
    2009-11-23

    (131 days)

    Product Code
    CBK, NOU
    Regulation Number
    868.5895
    Why did this record match?
    Applicant Name (Manufacturer) :

    VERSAMED MEDICAL SYSTEMS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The iVent101 ventilator [with single or dual limb configuration] is intended to provide continuous or intermittent ventilatory support for the care of invividuals who require mechanical ventilation. Specifically, the ventilator is applicable for infants from 5 kg through adult patients who require invasive or non-invasive support via the following ventilatory modalities: - Assist/Control and SIMV with either Volume, Pressure, or Pressure Regulated ● Volume Control (PRVC) - CPAP with Pressure Support - Adaptive Bi-Level for either NIV or invasive ventilation. . The iVent101 ventilator is suitable for use in institution, home and portable settings.
    Device Description
    The iVent101 is a compact, portable, microprocessor-controlled ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation .A turbine-powered air source and a rechargeable internal battery provide freedom from wall air and power outlets. Internal flow and pressure are read through flow/pressure sensors. Clinical data [Tidal Volume, Rate, PIP, FiG2, Peak Flow, Inspiratory Time, I:E Minute Volume] are presented on machine screen. All the operator actions are performed on the LCD touch-screen on the front panel, allowing rapid control and continuous real-time monitoring of patient ventilation. Alarm settings are fully adjustable. Optional Waveform and Diagnostic Software package displays pressure and flow waveform data, loops, trends, and logged totals in a full array of time slices and presentation modes. The iVent101 can use external AC or DC power supply and contains an integrated battery. The iVentiol is equipped with two configurations, which differs in the patient circuit type that connects to the machine. One configuration is to be used with a standard one limb patient circuit, and the second configuration is to be used with a standard dual limb patient circuit. The two configurations are incorporating the same infrastructure and can be easily replaced by the user.
    Ask a Question

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