Label: OXYGEN gas

  • NDC Code(s): 81313-001-01, 81313-001-02, 81313-001-03, 81313-001-04, view more
    81313-001-05, 81313-001-06, 81313-001-07, 81313-001-08, 81313-001-09, 81313-001-10, 81313-001-11, 81313-001-12, 81313-001-13, 81313-001-14, 81313-001-15, 81313-001-16, 81313-001-17, 81313-001-18, 81313-001-19
  • Packager: AMERICAN MEDICAL GAS RESOURCES LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated November 16, 2023

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  • PRINCIPAL DISPLAY PANEL

    OXYGEN, COMPRESSED U.S.P.

    UN1072

    Manufactured by:

    American Medical Gas Resources, LLC

    14915 S. 49th W. Avenue

    Kiefer, OK 74041

    DANGER:

    COMPRESSED, OXIDIZING GAS, MAY CAUSE OR INTENSIFY FIRE; OXIDIZER, CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED.

    In case of fire, stop leak if safe to do so. Keep reduction valves free from grease and oil. Open valve slowly. Store and use in a well ventilated place. Use a back flow preventive device in the piping. Close valve after each use and when empty. Protect from sunlight when ambient temperature exceeds 52 C/125 F. Container temperature should not exceeds 52 C/125 F. Do not handle until all safety precautions have been read and understood. Keep/store away from combustible materials. Use only with equipment cleaned for oxygen service and rated for cylinder pressure.

    DO NOT REMOVE THIS PRODUCT LABEL.

    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 or 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 resuscitation equipment.

    PRODUCED BY AIR LIQUEFACTION.

    LITERS CONTAINED

    X 170 X 255 X 425

    X 680 X 1699 X 2549

    X 3113 X 3455 X 7075

    X 8490 X OTHER oxygen

  • INGREDIENTS AND APPEARANCE
    OXYGEN 
    oxygen gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:81313-001
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN992 mL  in 1 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81313-001-0134 L in 1 CYLINDER; Type 0: Not a Combination Product12/17/2020
    2NDC:81313-001-02113 L in 1 CYLINDER; Type 0: Not a Combination Product12/17/2020
    3NDC:81313-001-03170 L in 1 CYLINDER; Type 0: Not a Combination Product12/17/2020
    4NDC:81313-001-04198 L in 1 CYLINDER; Type 0: Not a Combination Product12/17/2020
    5NDC:81313-001-05255 L in 1 CYLINDER; Type 0: Not a Combination Product12/17/2020
    6NDC:81313-001-06425 L in 1 CYLINDER; Type 0: Not a Combination Product12/17/2020
    7NDC:81313-001-07623 L in 1 CYLINDER; Type 0: Not a Combination Product12/17/2020
    8NDC:81313-001-08680 L in 1 CYLINDER; Type 0: Not a Combination Product12/17/2020
    9NDC:81313-001-091699 L in 1 CYLINDER; Type 0: Not a Combination Product12/17/2020
    10NDC:81313-001-102549 L in 1 CYLINDER; Type 0: Not a Combination Product12/17/2020
    11NDC:81313-001-113113 L in 1 CYLINDER; Type 0: Not a Combination Product12/17/2020
    12NDC:81313-001-123455 L in 1 CYLINDER; Type 0: Not a Combination Product12/17/2020
    13NDC:81313-001-137075 L in 1 CYLINDER; Type 0: Not a Combination Product12/17/2020
    14NDC:81313-001-148490 L in 1 CYLINDER; Type 0: Not a Combination Product12/17/2020
    15NDC:81313-001-15160 L in 1 DEWAR; Type 0: Not a Combination Product12/17/2020
    16NDC:81313-001-16180 L in 1 DEWAR; Type 0: Not a Combination Product12/17/2020
    17NDC:81313-001-17230 L in 1 DEWAR; Type 0: Not a Combination Product12/17/2020
    18NDC:81313-001-1846 L in 1 DEWAR; Type 0: Not a Combination Product12/17/2020
    19NDC:81313-001-1936 L in 1 DEWAR; Type 0: Not a Combination Product12/17/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20602312/17/2020
    Labeler - AMERICAN MEDICAL GAS RESOURCES LLC (031567551)
    Establishment
    NameAddressID/FEIBusiness Operations
    AMERICAN MEDICAL GAS RESOURCES LLC031567551manufacture(81313-001)
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