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510(k) Data Aggregation

    K Number
    K993773
    Device Name
    HUMID-HEAT
    Manufacturer
    Date Cleared
    2000-09-13

    (310 days)

    Product Code
    Regulation Number
    868.5450
    Why did this record match?
    Applicant Name (Manufacturer) :

    HUDSON RCJ AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Humid-Heat™ is an active respiratory humidifier that heats and humidifies dry breathing gases supplied from a ventilator via an endotracheal tube, a tracheostomy tube, or a face mask to adult patients under intensive care or anesthesia.
    Device Description
    Humid-Heat™ is an active respiratory humidifier that heats and humidifies dry breathing gases supplied from a ventilator via an endotracheal, tracheostomy tube or a face mask to adult patients under intensive care or anesthesia. Patients receive physiologically optimized breathing gases (37°C, 100% relative humidity) instead of the dry and cool breathing gases they would otherwise receive if connected directly to a ventilator. They thus avoid the thickened mucus, decreased cilia activity and secretions trapped in the lower airways that are often caused by exposure to cool, dry gases. By heating and humidifying the supplied breathing gases, Humid-Heat™ overcomes these problems and provides optimal conditions for long-term ventilation. Heating and humidification take place close to the patient, thereby eliminating the problem of condensation in ventilator circuits. Humid-Heat™ does not require any water traps or heated wires and water consumption is reduced. Humid-Heat™ is suitable for use with volume and pressure-controlled ventilators. The Humid-Heat™ consists of five main components: the supply unit, the heater, the temperature probe, the HME and the water feed set. It is controlled with a keypad consisting of four buttons; up/down buttons to set the minute volume of the ventilator, start button, stop button, and the power switch.
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