Product code OBN

Device name

Humidifier, Respiratory, Mask (Direct Patient Interface)

Medical specialty

Anesthesiology

Device class

2

Regulation number

868.5450

Review panel

AN

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

Y

Summary malfunction reporting

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.

Source

FDA openFDA device classification dataset