Label: OXYGEN gas

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved medical gas

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Drug Label Information

Updated January 1, 2020

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  • PRODUCT WARNINGS AND PRECAUTIONS

    DO NOT SMOKE NEAR THIS UNIT.  KEEP AWAY FROM HEAT, FLAME OR SPARKS.  KEEP UNIT WELL VENTILATED AT ALL TIMES.  DO NOT TOUCH FROSTED PARTS.  KEEP UNIT IN UPRIGHT POSITION.  READ PATIENT OPERATING INSTRUCTIONS.

  • UNIT LABELS

    HELIOS OXYGEN REFRIGERATED LIQUID USP OXYGEN - 2

    BY AIR LIQUEFACTION 7051529 REV A

    CAIRE HELIOS UNIVERSAL RESERVOIR 

    CAUTION: FEDERAL (USA) LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICAN

    IPX 1 MANUFACTURED BY CAIRE INC. 2200 AIRPORT INDUSTRIAL DRIVE STE 500 BALL GROUND, GA 30107 USE - 702104 REV B

    pulcs_liq_o2

    pulcs_liq_02_2

    res

  • INGREDIENTS AND APPEARANCE
    OXYGEN 
    oxygen gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:59704-0001
    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:59704-0001-121 L in 1 DEWAR; Type 0: Not a Combination Product01/01/1992
    2NDC:59704-0001-231 L in 1 DEWAR; Type 0: Not a Combination Product01/01/1992
    3NDC:59704-0001-336 L in 1 DEWAR; Type 0: Not a Combination Product01/01/1992
    4NDC:59704-0001-441 L in 1 DEWAR; Type 0: Not a Combination Product01/01/1992
    5NDC:59704-0001-545 L in 1 DEWAR; Type 0: Not a Combination Product01/01/1992
    6NDC:59704-0001-646 L in 1 DEWAR; Type 0: Not a Combination Product01/01/1992
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved medical gas01/01/1992
    Labeler - ALA Med dba Pulmonary Care Services (093185981)
    Registrant - ALA Med dba Pulmonary Care Services (093185981)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pulmonary Care Services093185981manufacture(59704-0001)
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