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U.S. Department of Health and Human Services

Product Classification

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Device humidifier, respiratory, mask (direct patient interface)
Regulation Description Respiratory gas humidifier.
Definition Intended to moderate blood pressure in hypertensive patients when they are exposed to the cold. The mask attenuates (moderates) the physiological response, increases in blood pressure, associated with cold exposure, by warming the inhaled air during cold exposure for individuals with hypertension, medicated or non-medicated.
Physical State A simple mask that is placed over the patient's nose and mouth, and held in place with an elastic band around the back of the head.
Technical Method Non-invasive heat-exchange device
Target Area Patient's nose/mouth area.
Regulation Medical Specialty Anesthesiology
Review Panel Anesthesiology
Product CodeOBN
Premarket Review Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
Submission Type 510(k)
Regulation Number 868.5450
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons