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Humidifier, Respiratory, Mask (Direct Patient Interface)

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.

Global Registration Data
Multi-Country Intelligence
Humidifier, Respiratory, Mask (Direct Patient Interface)
Anesthesiology Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

OBN

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Class 2

21 CFR 868.5450

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Anesthesiology

Device Characteristics

No

No

No

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.