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U.S. Department of Health and Human Services

Product Classification

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Device high flow/high velocity humidified oxygen delivery device
Regulation Description High flow humidified oxygen delivery device.
Definition Intended to deliver high flow and/or high velocity oxygen with humidification.
Physical State This device can have a means of delivering humidified high flow and/or high velocity oxygen that may include high flow nasal cannula. The device may have a mechanical means of blending oxygen to the appropriate concentration.
Technical Method The device introduces humidified high flow and/or high velocity oxygen into the respiratory system.
Target Area Lung, airways, nasal passages
Regulation Medical Specialty Anesthesiology
Review Panel Anesthesiology
Product CodeQAV
Premarket Review Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
Submission Type 510(k)
Regulation Number 868.5454
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standard
Third Party Review Not Third Party Eligible
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