OXYGEN by Premier Medical Corporation OXYGEN gas

OXYGEN by

Drug Labeling and Warnings

OXYGEN by is a Prescription medication manufactured, distributed, or labeled by Premier Medical Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

OXYGEN REFRIGERATED LIQUID

OXYGEN REFRIGERATED LIQUID USP UN1073  CONTENTS_________ LITERS  ALWAYS KEEP CONTAINER IN UPRIGHT POSITION.  WARNING: DO NOT CHANGE OR FORCE FIT CONNECTIONS.  EXTREMELY COLD LIQUID AND GAS UNDER PRESSURE.  VIGOROUSLY ACCELERATES COMBUSTION.  NO SMOKING IN THE PRESENCE OF OXYGEN OR A FIRE MAY RESULT.  COMBUSTIBLES IN CONTACT WITH LIQUID OXYGEN MAY EXPLODE ON IGNITION OR IMPACT.  CAN CAUSE SEVERE FROSTBITE.  KEEP OIL, GREASE AND COMBUSTIBLES AWAY.  USE ONLY WITH EQUIPMENT CLEANED FOR OXYGEN SERVICE.  STORE AND USE WITH ADEQUATE VENTILATION.  DO NOT GET LIQUID IN EYES, ON SKIN OR CLOTHING.  FOR LIQUID WITHDRAWAL, WEAR FACE SHIELD AND GLOVES.  DO NOT DROP.  USE SUITABLE HAND TRUCK FOR CONTAINER MOVEMENT.  AVOID SPILLS.  DO NOT WALK OR ROLL EQUIPMENT OVER SPILLS  CONTAINER TEMPERATURE SHOULD NOT EXCEED 52C (125 F)  CLOSE VALVE AFTER EACH USE AND WHEN EMPTY.  USE A BACK FLOW PREVENTATIVE DEVICE IN THE PIPING.  USE IN ACCORDANCE WITH THE MATERIAL SAFETY DATA SHEET (MSDS)  

FIRST AID: IN CASE OF FROSTBITE OBTAIN MEDICAL TREATMENT IMMEDIATELY.

WARNING: FOR EMERGENCY USE ONLY WHEN ADMINISTERED BY PROPERLY 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.  PRODUCED BY AIR LIQUEFACTION.  DO NOT REMOVE THIS PRODUCT LABEL.

INGREDIENTS AND APPEARANCE

OXYGEN 
oxygen gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 61604-9068
Route of Administration	RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065)	OXYGEN	99 L  in 100 L

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61604-9068-1	18060 L in 1 DEWAR; Type 0: Not a Combination Product	01/01/1993
2	NDC: 61604-9068-2	26660 L in 1 DEWAR; Type 0: Not a Combination Product	01/01/1993
3	NDC: 61604-9068-3	30960 L in 1 DEWAR; Type 0: Not a Combination Product	01/01/1993
4	NDC: 61604-9068-4	35260 L in 1 DEWAR; Type 0: Not a Combination Product	01/01/1993
5	NDC: 61604-9068-5	38700 L in 1 DEWAR; Type 0: Not a Combination Product	01/01/1993
6	NDC: 61604-9068-6	39560 L in 1 DEWAR; Type 0: Not a Combination Product	01/01/1993

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA206023	01/01/1993

Labeler - Premier Medical Corporation (804710358)

Registrant - Premier Medical Corporation (804710358)

Establishment
Name	Address	ID/FEI	Business Operations
Premier Medical Corporation		804710358	manufacture(61604-9068)

Establishment
Name	Address	ID/FEI	Business Operations
Premier Medical Corporation		832849546	manufacture(61604-9068)

Establishment
Name	Address	ID/FEI	Business Operations
Premier Medical Corporation		962391624	manufacture(61604-9068)

Establishment
Name	Address	ID/FEI	Business Operations
Premier Medical Corporation		079806580	manufacture(61604-9068)