OXYGEN GAS [PREMIER MEDICAL CORPORATION]

OXYGEN GAS [PREMIER MEDICAL CORPORATION]
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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
  • 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.

    LIQUID LABEL

  • INGREDIENTS AND APPEARANCE
    OXYGEN 
    oxygen gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:61604-9068
    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:61604-9068-118060 L in 1 DEWAR; Type 0: Not a Combination Product01/01/1993
    2NDC:61604-9068-226660 L in 1 DEWAR; Type 0: Not a Combination Product01/01/1993
    3NDC:61604-9068-330960 L in 1 DEWAR; Type 0: Not a Combination Product01/01/1993
    4NDC:61604-9068-435260 L in 1 DEWAR; Type 0: Not a Combination Product01/01/1993
    5NDC:61604-9068-538700 L in 1 DEWAR; Type 0: Not a Combination Product01/01/1993
    6NDC:61604-9068-639560 L in 1 DEWAR; Type 0: Not a Combination Product01/01/1993
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20602301/01/1993
    Labeler - Premier Medical Corporation (804710358)
    Registrant - Premier Medical Corporation (804710358)
    Establishment
    NameAddressID/FEIBusiness Operations
    Premier Medical Corporation804710358manufacture(61604-9068)
    Establishment
    NameAddressID/FEIBusiness Operations
    Premier Medical Corporation832849546manufacture(61604-9068)
    Establishment
    NameAddressID/FEIBusiness Operations
    Premier Medical Corporation962391624manufacture(61604-9068)
    Establishment
    NameAddressID/FEIBusiness Operations
    Premier Medical Corporation079806580manufacture(61604-9068)

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