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Humidifier, Respiratory, Mask (Direct Patient Interface)

FDA product code OBN · 1 cleared devices

Class 2 Anesthesiology
Regulation
21 CFR 868.5450
Review panel
AN
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2007-04-17 – 2007-04-17

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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