NDC | 61604-9068-1, 61604-9068-2, 61604-9068-3, 61604-9068-4, 61604-9068-5, 61604-9068-6 |
Set ID | 2a516840-f0a6-4651-9ec1-7520a2bfe7ad |
Category | HUMAN PRESCRIPTION DRUG LABEL |
Packager | Premier Medical Corporation |
Generic Name | |
Product Class | |
Product Number | |
Application Number | NDA206023 |
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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 gasProduct 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)