FDA product code NHK

Resuscitator, Manual, Non Self-Inflating

Anesthesiology·Class 2·21 CFR 868.5905·Life-sustaining
US regulatory classifications
US Product Code (FDA)
NHK
View Product Code Classification →
US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 868.5905
View CFR Regulation →
Medical specialty
Anesthesiology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
Yes
Third party review
Not Eligible
Definition

A non self-inflating manual resuscitator, also called a hyperinflation system, is a manual ventilator intended to ventilate a patient by forcing a volume of fresh gas into the patient via compression of the ventilator bag; a source of compressed breathing gas is required to inflate the bag.

Search keywords
About this record

Resuscitator, Manual, Non Self-Inflating 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.