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510(k) Data Aggregation
K Number
K193411Device Name
O2asis Personal Oxygen Humidifier
Manufacturer
Date Cleared
2020-11-12
(339 days)
Product Code
Regulation Number
868.5450Why 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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