Label: OXYGEN gas

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

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated December 1, 2011

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  • OXYGEN PURITY TAG

    LOT NUMBER____ SERIAL NUMBER________ AMOUNT_____________ INS. LBS GALS LITERS CU FT

    USP TESTS

    TEST           ID        ODOR        ASSAY

    LIMITS        OK        NONE        GREATER THAN OR EQUAL TO 99.2%

    RESULTS __        _____            _______

    FOR CUSTOMER USE TO DOCUMENT TESTS PERFORMED ON THIS VESSEL

    METHOD OF ANALYSIS IS THE PARAMAGNETIC OXYGEN ANALYZER

    MANUFACTURER __________  MODEL ________ CUSTOMER WITNESSED TESTS YES__ MO___  SUPPLIERS SIGNATURE _____________  DATE____ CUSTOMER'S SIGNATURE___________ DATE___________

    LIQUID OXYGEN DELIVERY TAG  THIS VESSEL CONTAINS OXYGEN U.S.P. (SEE REVERSE SIDE FOR TEST RESULTS) OXYGEN PRODUCED BY THE AIR LIQUEFACTION PROCESS - MEDICAL GASES

    PURITY TAG

  • PRODUCT WARNINGS

    THIS VESSEL CONTAINS OXYGEN U.S.P. (SEE REVERSE SIDE FOR TEST RESULTS)  OXYGEN PRODUCED BY THE AIR LIQUEFACTION PROCESS.

  • INGREDIENTS AND APPEARANCE
    OXYGEN 
    oxygen gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:58977-001
    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:58977-001-0121 L in 1 DEWAR
    2NDC:58977-001-0231 L in 1 DEWAR
    3NDC:58977-001-0336 L in 1 DEWAR
    4NDC:58977-001-0441 L in 1 DEWAR
    5NDC:58977-001-0546 L in 1 DEWAR
    6NDC:58977-001-06169 L in 1 DEWAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved medical gas01/01/1998
    Labeler - Rice Home Medical LLC (603626920)
    Registrant - Rice Home Medical LLC (603626920)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rice Home Medical LLC603626920manufacture