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510(k) Data Aggregation

    K Number
    K133766
    Device Name
    HUMICARE D900
    Manufacturer
    Date Cleared
    2014-11-24

    (348 days)

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

    GRUENDLER GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Gründler's HumiCare D900 system is intended to heat and humidify medical respiratory gases for patients. The device is for use during artificial ventilatory support (e.g. invasve ventilation via tracheal tube or cannula), non-invasive ventilation, or respiratory therapy by means of a mask or other patient interface. Heated breathing circuits are intended to provide warmed and/or humidified breathing gases before entering the patient airway reducing or eliminating water. They are accessories for the Gründler's HumiCare D900. The heated breath or flow rates greater than 3L/min. The system is for use in hospital/institutional environment or in the home environment by medically trained healthcare users.
    Device Description
    The HumiCare D900 system is a respiratory gas humidifier according to 21 CFR §868.5450. A respiratory gas humidifier is identified by the Food and Drug Administration (FDA) as a therapeutic device that is intended to warm and add humidity. The HumiCare D900 including heated air tubings is an active heated humidifier which employs a pass-over humidification via an enhanced surface area for gas/water. The huge gas/water surface area is resulting in an output of gas with a temperature almost identical to that of the water with a relative humidity of 100%. The principle operation of the HumiCare D900 is to direct the gas mixture from the ventilator's outlet into the humidifier's water chamber via air tubing. There it is heated and humidified by means of heated water. A heated inspiratory tube is used to transport the conditioned gas from the water chamber's outlet to the patient. Depending on the patient interface an inspiratory tube or inspiratory and expiratory tubes can be used for the humidification with HumiCare D900. The inspiratory limb can further include an antibacterial filter with filter heater to reduce condensation. In order to minimize condensation (rain out), both inspiratory and expiratory air tubing can be actively heated. Therefore a temperature sensor is included in the inspiratory air tubing to control the temperature regulation of the air tubing.
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