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    K Number
    K232365

    Validate with FDA (Live)

    Device Name
    Vivo 45 LS
    Manufacturer
    Oconnell Regulatory Consultants, Inc.
    Date Cleared
    2025-12-19

    (865 days)

    Product Code
    CBK,BTT,CCK,DQA,NOU
    Regulation Number
    868.5895
    Type
    Traditional
    Panel
    Anesthesiology
    Age Range
    All
    Reference & Predicate Devices
    K193586,K181166
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K193586, K181166

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Vivo 45 LS ventilator (with or without the SpO2 and CO2 sensors) is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for pediatric through adult patients weighing more than 5 kg (11 lbs.), however, the mouthpiece ventilation and Auto EPAP modes are only for adult patients during non-invasive ventilation.

    The Vivo 45 LS with the SpO2 sensor is intended to measure functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate.

    The Vivo 45 LS with the CO2 sensor is intended to measure CO2 in the inspiratory and expiratory gas.

    The device is intended to be used in home, institution, hospitals and portable applications such as wheelchairs and gurneys. It may be used for both invasive and non-invasive ventilation. The Vivo 45 LS is not intended to be used as an emergency transport or critical care ventilator. The Auto EPAP feature is for use with PSV+TgV+AE mode in hospital use only.

    Device Description

    The Vivo 45 LS Ventilator is a portable, microprocessor controlled turbine based pressure support, pressure control or volume controlled ventilator intended for the care of individuals who require mechanical ventilation.

    Flow and pressure are read using flow and pressure sensors. Essential parameters such as pressure, flow and volume are presented on the ventilator screen, both in the form as graphs and numbers.

    Operator actions are performed via the front panel where the buttons and an LCD screen are located (and two dedicated buttons on the top of the ventilator control starting/stopping treatment and pausing the alarm audio). There are dedicated LEDs and buttons for managing alarm conditions and an Information button which provides integrated user support.

    The Vivo 45 LS can be operated by external AC or DC power supply and contains an integrated battery as well as an optional click in battery.

    The Vivo 45 LS can be used with two types of patient circuits: single limb patient circuits including an active exhalation valve and single limb patient circuits including a passive leakage port.

    AI/ML Overview

    N/A

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