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510(k) Data Aggregation

    K Number
    K180474
    Device Name
    TNI softFlow 50
    Manufacturer
    TNI Medical AG
    Date Cleared
    2018-10-18

    (238 days)

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

    TNI Medical AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TNI softFlow 50 is for the treatment of spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases. The TNI softFlow 50 is for adult patients in hospitals and long-term care facilities. The flow may be from 10-50 L/min. The TNI softFlow 50 is not indicated for life support measures.
    Device Description
    The softFlow 50 system is a high flow heated humidifier for respiratory gases with integrated flow source and a heated breathing tube to deliver conditioned respiratory gases to a patient. The air or air/oxygen mixture is both humidified and heated. A nasal cannula serves as applicator, similar to the nasal cannula used during oxygen ventilation therapy. The nasal applicator is no compatible with a tracheostoma. The nasal applicator is sold separately as a disposable accessory that is replaced after 14 days (336 hours). The softFlow 50 is for the treatment of spontaneously breathing adult patients in hospitals and long-term care facilities who would benefit from receiving high flow warmed and humidified respiratory gases. The flow may be from 10-50 L/min depending on the patient interface. The humidifier clinic complete is sold separately so that the patient can replace the airlift, the humidification chamber, and the bacterial filter. The humidifier clinic is sold separately as a disposable accessory that is replaced weekly.
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