Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K241366
    Device Name
    QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV)
    Manufacturer
    DEHAS Medical Systems GmbH
    Date Cleared
    2024-10-29

    (168 days)

    Product Code
    CBP, CBK
    Regulation Number
    868.5870
    Why did this record match?
    Applicant Name (Manufacturer) :

    DEHAS Medical Systems GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The demand valve is used for the application of 100 vol% oxygen during manual ventilation with the resuscitator bag, as well as during direct non-invasive inhalation with the resuscitator mask in spontaneously breathing patients.
    Device Description
    The valve, non - rebreathing QualityFlow O2 demand valve is a medical device to deliver medical oxygen or a medical air - oxygen mixture to a patient on demand. Unlike continuous oxygen systems, the demand valve only supplies medical gas when the patient inhales, reducing oxygen consumption and ensuring the patient receives gas only when needed. The QualityFlow O2 Demand Valve from DEHAS consists of a membrane that is activated by negative pressure during inspiration and a valve mechanism that controls gas flow. During inspiration, the valve opens due to the movement of the membrane, while during expiration it is closed by a return spring. The function of the demand valve is based on providing gas only when a negative pressure is applied to the membrane, e.g. by the patient inhaling with a connected mask or suction of the resuscitator when connected (expansion after previous compression of the resuscitator). The valve therefore ensures that gas only flows when it is needed.
    Ask a Question
    K Number
    K221494
    Device Name
    Quality Mix Blender, Oxymixer
    Manufacturer
    DEHAS Medical Systems GmbH
    Date Cleared
    2023-01-23

    (245 days)

    Product Code
    BZR
    Regulation Number
    868.5330
    Why did this record match?
    Applicant Name (Manufacturer) :

    DEHAS Medical Systems GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The air-oxygen mixer Quality Mix is used to administer a continuous, precise mix of medical air and medical oxygen through its outlet ports - to infants, children and adults. The exact fractional inspiratory oxygen concentration (FiO2) corresponds to the selected FiO2 setting on the control knob (dial). It is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician in professional healthcare settings. This product is not intended for use as a life supporting device. Warning: By using flows above 70 LPM, the risk of high flow such as ar trapping, barotrauma, and gastric insufflation (leading to possible aspiration) can occur.
    Device Description
    The air-oxygen blender Quality Mix is a compact air/oxygen mixing device, which provides a precise mixing of medical grade air and oxygen gases. The blender is a pneumatic powered device with flowmeters which can be connected to outlet ports to regulate the gas flow. The Quality Mix series medical air / oxygen blender includes following models: Quality Mix High Flow; Quality Mix High Flow XL and Quality Mix Low Flow; Quality Mix Low Flow XL. The Quality Mix series air / oxygen blender is designed, tested and manufactured in accordance with the standard ISO 11195:2018 Gas mixers for medical use - Stand - alone qas mixers.
    Ask a Question

    Page 1 of 1