Drug Labeling and Warnings

Drug Details

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OXYGEN - oxygen gas 
Respitek Inc

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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OXYGEN COMPRESSED LABEL

OXYGEN COMPRESSED USP  UN 1072 OXYGEN-2  DO NOT REMOVE THIS PRODUCT LABEL

WARNING: FOR EMERGENCY USE ONLY WHEN ADMINISTERED BY TRAINED PERSONNEL FOR OXYGEN DEFICIENCY AND RESUSCITATION.  FOR ALL OTHER MEDICAL APPLICATIONS Rx ONLY.  UNINTERRUPTED USE OF HIGH CONCENTRATIONS OF OXYGEN OVER A LONG DURATION WITHOUT MONITORING ITS EFFECT ON OXYGEN CONTENT OF ARTERIAL BLOOD MAY BE HARMFUL.  USE ONLY WITH PRESSURE REDUCING EQUIPMENT AND APPARATUS DESIGNED FOR OXYGEN.  DO NOT ATTEMPT TO USE ON PATIENTS WHO HAVE STOPPED BREATHING UNLESS USED IN CONJUNCTION WITH RESUSCITATIVE EQUIPMENT.

18278 (08/04)

SHOULDER LABEL

PRODUCT WARNINGS AND PRECAUTIONS

WARNING: HIGH PRESSURE OXIDIZING GAS VIGOROUSLY ACCELERATES COMBUSTION.  KEEP OIL AND GREASE AWAY.  OPEN VALVE SLOWLY.  STORE AND USE WITH ADEQUATE VENTILATION.  USE ONLY WITH EQUIPMENT CLEANED FOR OXYGEN SERVICE AND RATED FOR CYLINDER PRESSURE.  USE A BACK FLOW PREVENTATIVE DEVICE IN THE PIPING.  CLOSE VALVE AFTER EACH USE AND WHEN EMPTY.  CYLINDER TEMPERATURE SHOULD NOT EXCEED 52 C (125 F).  USE IN ACCORDANCE WITH THE MATERIAL SAFETY DATA SHEET (MSDS)  CAS 7782-44-7  RETURN WITH 25 PSIG.  PRODUCED BY AIR LIQUEFACTION.  REFILLABLE ONLY BY RESPITEK OXYGEN SERVICE.

OXYGEN 
oxygen gas
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 58247-001
Route of AdministrationRESPIRATORY (INHALATION)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN99 L  in 100 L
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 58247-001-01248 L in 1 CYLINDER
2NDC: 58247-001-02426 L in 1 CYLINDER
3NDC: 58247-001-03671 L in 1 CYLINDER
4NDC: 58247-001-043462 L in 1 CYLINDER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved medical gas01/01/1981
Labeler - Respitek Inc (093592954)
Registrant - Respitek Inc (093592954)
Establishment
NameAddressID/FEIBusiness Operations
Respitek Inc093592954manufacture

Revised: 1/2010
 
Respitek Inc


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