OXYGEN GAS [ISLAND RESPIRATORY CARE, INC]

OXYGEN GAS [ISLAND RESPIRATORY CARE, INC]
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NDC 51561-001-01, 51561-001-02, 51561-001-03, 51561-001-04, 51561-001-05
Set ID 4eb965ff-09e5-4b73-ba4a-601bd1ab56ee
Category HUMAN PRESCRIPTION DRUG LABEL
Packager Island Respiratory Care, Inc
Generic Name
Product Class
Product Number
Application Number
  • 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:51561-001
    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:51561-001-0121 L in 1 DEWAR
    2NDC:51561-001-0231 L in 1 DEWAR
    3NDC:51561-001-0336 L in 1 DEWAR
    4NDC:51561-001-0441 L in 1 DEWAR
    5NDC:51561-001-0545 L in 1 DEWAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved medical gas03/01/2010
    Labeler - Island Respiratory Care, Inc (962072182)
    Registrant - Island Respiratory Care, Inc (962072182)
    Establishment
    NameAddressID/FEIBusiness Operations
    Island Respiratory Care, Inc962072182manufacture

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