FDA product code NOU

Continuous, Ventilator, Home Use

Anesthesiology·Class 2·21 CFR 868.5895·Life-sustaining
US regulatory classifications
US Product Code (FDA)
NOU
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 868.5895
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Medical specialty
Anesthesiology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
Yes
Third party review
Not Eligible
Definition

This product code was needed for the home use indication. CBK is not a tracked device and NOU is a tracked device.

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About this record

Continuous, Ventilator, Home Use 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. This device type includes life-sustaining products.

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.