Label: OXYGEN gas

  • Contains inactivated NDC Code(s)
    NDC Code(s):
    48883-001-01, 48883-001-02, 48883-001-03, 48883-001-04, view more
    48883-001-05, 48883-001-06, 48883-001-07, 48883-001-08, 48883-001-09, 48883-001-10, 48883-001-11, 48883-001-12, 48883-001-13, 48883-001-14, 48883-001-15, 48883-001-16, 48883-001-17
  • Packager: Encompass Medical & Specialty Gases, Ltd.
  • 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 January 9, 2011

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  • PRINCIPAL DISPLAY PANEL

    OXYGEN, Compressed USP UN1072       OXYGEN 2         16639 (R 08/10)     
    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 use with oxygen. Do not attempt to use on patients who have stopped breathing unless used in conjunction with resuscitative equipment. Produced by Air Liquefaction. WARNING: HIGH PRESSURE OXIDIZING GAS. VIGOROUSLY ACCELERATES COMBUSTION. Keep oil and grease away. Open valve slowly. Store and use with adequate ventilation. Use only with equipment cleaned for Oxygen service and rated for cylinder pressure. Use a back flow preventive device in the piping. Close valve after each use and when empty. Cylinder temperature should not exceed 52 C (125F). Use in accordance with Material Safety Data Sheet (MSDS).
    CAS: 7782-44-7    RETURN WITH 25 PSIG
    DO NOT REMOVE THIS PRODUCT LABEL.
    Cylinders must be refilled by:
    Encompass Medical and Specialty Gases, LTD. 4646 Linden Road P.O. Box 5404 Rockford, IL 61109
    CONTENTS:  690 LTRS    CYL. SIZE E    TOP PSIG at 70 F    2015
    Oxygen Label 2
  • PRINCIPAL DISPLAY PANEL

    REFRIGERATED LIQUID
    OXYGEN, REFRIGERATED LIQUID USP UN1073       OXYGEN 2
    ALWAYS KEEP CONTAINER IN UPRIGHT POSITION. DO NOT CHANGE OR FORCE FIT CONNECTIONS.
    CONTENTS: LTRS.     CU. FT.
    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 use with oxygen. Do not attempt to use on patients who have stopped breathing unless used in conjunction with resuscitative equipment. Produced by Air Liquefaction.
    WARNING: EXTREMELY COLD, OXIDIZING LIQUID AND GAS UNDER PRESSURE . VIGOROUSLY ACCELERATES COMBUSTION. 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. 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. O not walk on or roll equipment over spills. Cylinder temperature should not exceed 52 C (125F).  Close valve after each use and when empty. Use a back flow preventive device in the piping. Use in accordance with Material Safety Data Sheet (MSDS). FIRST AID : IN CASE OF FROSTBITE, obtain medical treatment immediately.
    CAS: 7782-44-7    
    DO NOT REMOVE THIS PRODUCT LABEL.
    Cylinders must be refilled by:
    Encompass Medical and Specialty Gases, LTD. 4646 Linden Road P.O. Box 5404 Rockford, IL 61109
    47136 (R 10/05)
    Oxygen Label 4
  • PRINCIPAL DISPLAY PANEL

    Produced by air liquefaction
    OXYGEN, Compressed U.S.P. UN1072       OXYGEN 2             
    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. Do not attempt to use on patients who have stopped breathing unless used in conjunction with resuscitative equipment.
    WARNING: HIGH PRESSURE OXIDIZING GAS. VIGOROUSLY ACCELERATES COMBUSTION.
    Use only with pressure reducing equipment and apparatus cleaned and designed for oxygen service and rated for cylinder pressure. Open valve slowly. Close valve after each use and when empty. Keep cylinder, cylinder valve, all equipment that connects, free of oil and grease to avoid violent ignition. Federal law requires that this container be refilled with oxygen USP only by establishments registered as a drug manufacturer in accordance with the Federal Food, Drug and Cosmetic Act. Pursuant to recommendations by the Compressed Gas Association, do not expose pressurized cylinders to temperatures in excess of 125F. DO NOT REMOVE THIS PRODUCT LABEL.
    Use a back flow preventive device in the piping. Use only in accordance with product instructions and Material Safety Data Sheet.
    Cylinders must be refilled by:
    Encompass Medical and Specialty Gases, LTD. 4646 Linden Road P.O. Box 5404 Rockford, IL 61109
    CAS: 7782-44-7    RETURN WITH 25 PSIG
    DO NOT REMOVE THIS PRODUCT LABEL
    Cylinder contents at 70F
    Cylinder size
    Size E 690 liters 2015 PSIG
    Size D 420 Liters 2015 PSIG
    Size M6 164 Liters 2015 PSIG
    STORE AND USE WITH ADEQUATE VENTILATION
    Date: 0810 Label:0035-647
    Oxygen Label 5
  • INGREDIENTS AND APPEARANCE
    OXYGEN 
    oxygen gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:48883-001
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Oxygen (UNII: S88TT14065) (Oxygen - UNII:S88TT14065) Oxygen990 mL  in 1 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:48883-001-01113 L in 1 CYLINDER
    2NDC:48883-001-02165 L in 1 CYLINDER
    3NDC:48883-001-03171 L in 1 CYLINDER
    4NDC:48883-001-04248 L in 1 CYLINDER
    5NDC:48883-001-05420 L in 1 CYLINDER
    6NDC:48883-001-06647 L in 1 CYLINDER
    7NDC:48883-001-07690 L in 1 CYLINDER
    8NDC:48883-001-081699 L in 1 CYLINDER
    9NDC:48883-001-091846 L in 1 CYLINDER
    10NDC:48883-001-102497 L in 1 CYLINDER
    11NDC:48883-001-113511 L in 1 CYLINDER
    12NDC:48883-001-123470 L in 1 CYLINDER
    13NDC:48883-001-134361 L in 1 CYLINDER
    14NDC:48883-001-146900 L in 1 CYLINDER
    15NDC:48883-001-159340 L in 1 CYLINDER
    16NDC:48883-001-16127427 L in 1 CYLINDER
    17NDC:48883-001-1764308 L in 1 CYLINDER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved medical gas01/01/1955
    Labeler - Encompass Medical & Specialty Gases, Ltd. (963344143)
    Establishment
    NameAddressID/FEIBusiness Operations
    Encompass Medical & Specialty Gases, Ltd.963344143manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Encompass Medical & Specialty Gases, Ltd.963719286manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Encompass Medical & Specialty Gases, Ltd.963719096manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Encompass Medical & Specialty Gases, Ltd.963718361manufacture