Product code OLF

Device name

Medevac Use Oxygen Generator

Medical specialty

Anesthesiology

Device class

2

Regulation number

868.5440

Review panel

AN

Implant

N

Life sustaining/supporting

Y

GMP exempt

N

Third party review

N

Summary malfunction reporting

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.

Source

FDA openFDA device classification dataset