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Humidifier, Respiratory, Mask (Direct Patient Interface)

Page Type
Product Code
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
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
868.5450
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 868.5450 Respiratory gas humidifier

§ 868.5450 Respiratory gas humidifier.

(a) Identification. A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device.

(b) Classification. Class II (performance standards).

Humidifier, Respiratory, Mask (Direct Patient Interface)

Page Type
Product Code
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
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
868.5450
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 868.5450 Respiratory gas humidifier

§ 868.5450 Respiratory gas humidifier.

(a) Identification. A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device.

(b) Classification. Class II (performance standards).