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510(k) Data Aggregation

    K Number
    K113542
    Device Name
    SALTER LABS BUBBLE HUMIDIFIER (HIGH FLOW)
    Manufacturer
    SALTER LABS, ARVIN FACILITY
    Date Cleared
    2012-02-10

    (71 days)

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

    SALTER LABS, ARVIN FACILITY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The bubble humidifier is a device that is intended to add moisture to breathing gases for administration to a patient. The bubble humidifier is indicated for use with oxygen concentrators or gas sources in homecare, hospital, extended care facilities and hospice environments. The bubble humidifier is a non-sterile device indicated for single-patient usage. The device is indicated for patients who require humidification of high flow supplemental breathing gases.
    Device Description
    The Salter Labs Bubble Humidifier (High Flow) is an empty, disposable, non-sterile device that is intended to humidify breathing gas prior to delivery to a patient. The Salter Labs Bubble Humidifier (High Flow) is provided with a 6 PSI safety valve and can operate within flow rates of 6 to 15 LPM. The device is used with various breathing gas sources (i.e., oxygen concentrators, gas cylinders and wall outlets) and provides connection for delivery of humidified breathing gas via face masks and cannulas, and use of optional oxygen tubing and water traps. The device is made of a humidifier bottle which is used to hold water during use, a lid which seals the humidifier bottle and houses the different interface connectors, an audible pressure relief mechanism to notify the user of a downstream occlusion and a diffuser located inside the humidifier bottle that is designed to uniformly disperse the gas throughout the water. The 360° diffuser ports also provide quiet operation and minimize system backpressure. Both the bottle and lid are constructed to be easy to grip and reduce the chance of cross threading. The jar is permanently marked with minimum/maximum water levels.
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