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FDA product code OBN

Humidifier, Respiratory, Mask (Direct Patient Interface)

AnesthesiologyClass 221 CFR 868.5450
US regulatory classifications
US Product Code (FDA)
OBN
US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 868.5450
Medical specialty
Anesthesiology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Eligible
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.

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About this record

Humidifier, Respiratory, Mask (Direct Patient Interface) is a medical device type in the Anesthesiology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.