FDA product code OLF

Medevac Use Oxygen Generator

Anesthesiology·Class 2·21 CFR 868.5440·Life-sustaining
US regulatory classifications
US Product Code (FDA)
OLF
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 868.5440
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Medical specialty
Anesthesiology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
Yes
Third party review
Not Eligible
Definition

A MEDEVAC oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve) to be used exclusively aboard a MEDEVAC helicopter and affixed to the helicopter. For general use portable oxygen generators, use product code CAW.

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About this record

Medevac Use Oxygen Generator 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.