May 2003 - FDA - CDER - Guidance for Industry - GMP for Medical Gases
http://www.fda.gov/OHRMS/DOCKETS/98fr/03d-0165-gdl0001.pdf
states that the labeling for medical oxygen must contain the statement:
"For emergency use only when administered by properly
trained personnel for oxygen deficiency and resuscitation.
For all other medical applications, Rx Only."
| Proper training may be obtained through: |
| AHA - American Heart Association |
ARC - American Red Cross |
| HSI - Health & Safety Institute/ASHI/Medic |
National Safety Council |
| ...and affiliated training agencies and local fire departments |
Additionally, instructions for the operation of all LIFEŽ emergency oxygen units are
printed on each easy-to-use LIFEŽOxygenPac, LIFEŽSoftPac, and LIFEŽO2 unit.
|