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510(k) Data Aggregation

    K Number
    K193411
    Device Name
    O2asis Personal Oxygen Humidifier
    Manufacturer
    Date Cleared
    2020-11-12

    (339 days)

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

    Perma Pure LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The O2asis Personal Oxygen Humidifier is indicated to add moisture and may warm breathing gases for administration to infant, pediatric and adult patients in the home, hospital, and clinical settings. It is used with an external gas source of up to 6 Lpm via nasal cannula.
    Device Description
    The O₂asis Personal Oxygen Humidifier is a self-contained, palm-sized, mobile device, making it possible for an individual to move the system to a new location without assistance. The O₂asis Personal OxygenHumidifier provides heat and humidified gas when used with a home oxygen concentrator or cylinder supply with flow rates up to 6 lpm. The subject device humidifies and heats the gas (oxygen) and delivers the warmed gas via a nasal cannula. When unplugged, the subject device provides passive humidification but no heat.
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