OXYGEN GAS [HAUN SPECIALTY GASES, INC.]

OXYGEN GAS [HAUN SPECIALTY GASES, INC.]
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NDC 14961-001-01, 14961-001-02, 14961-001-03, 14961-001-04, 14961-001-05, 14961-001-06, 14961-001-07, 14961-001-08, 14961-001-09, 14961-001-10, 14961-001-11, 14961-001-12, 14961-001-13, 14961-001-14, 14961-001-15, 14961-001-16, 14961-001-17, 14961-001-18, 14961-001-19
Set ID f66537e7-80eb-47e5-8319-44e606c8a08f
Category HUMAN PRESCRIPTION DRUG LABEL
Packager Haun Specialty Gases, Inc.
Generic Name
Product Class
Product Number
Application Number NDA205767
  • PRINCIPAL DISPLAY PANEL

    OXYGEN, COMPRESSED USP UN1072 PRODUCED BY AIR LIQUIFACTION 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. Keep out of reach of children. 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.
    DANGER: MAY CAUSE OR INTENCIFY FIRE; OXYDIZER. CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED. Do not handle until all safety precautions have been read and understood. Keep and store away from clothing and other combustible materials. Keep valves and fittings free from grease and oil. Use and store only outdoors or in a well-ventilated place. In case of fire; Stop leak if safe to do so. Use a back flow preventive device in the piping. Use only with equipment of compatible materials of construction and rated for cylinder pressure. Use only with equipment cleaned for oxygen service. Open valve slowly. Close valve after each use and when empty. Protect from sunlight when ambient temperature exceeds 52 C (125 F). Read and follow the Safety Data Sheet (SDS) before use.
    CAS: 7782-44-7 DO NOT REMOVE THIS PRODUCT LABEL
    CONTENTS: LTRS CU. FT.
    HAUN COMPANIES 5921 COURT STREET ROAD . SYRACUSE, NY 13206 315-463-5241 oxygen one

  • PRINCIPAL DISPLAY PANEL

    OXYGEN, COMPRESSED USP UN1072 PRODUCED BY AIR LIQUIFACTION 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. Keep out of reach of children. 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.
    DANGER: MAY CAUSE OR INTENCIFY FIRE; OXYDIZER. CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED. Do not handle until all safety precautions have been read and understood. Keep and store away from clothing and other combustible materials. Keep valves and fittings free from grease and oil. Use and store only outdoors or in a well-ventilated place. In case of fire; Stop leak if safe to do so. Use a back flow preventive device in the piping. Use only with equipment of compatible materials of construction and rated for cylinder pressure. Use only with equipment cleaned for oxygen service. Open valve slowly. Close valve after each use and when empty. Protect from sunlight when ambient temperature exceeds 52 C (125 F). Read and follow the Safety Data Sheet (SDS) before use.
    CAS: 7782-44-7 DO NOT REMOVE THIS PRODUCT LABEL
    HAUN COMPANIES 5921 COURT STREET ROAD . SYRACUSE, NY 13206 315-463-5241 oxygen two

  • PRINCIPAL DISPLAY PANEL

    OXYGEN, REFRIGERATED LIQUID USP UN1073 OXYGEN 2 Produced by Air Liquefaction. DO NOT REMOVE THIS PRODUCT LABEL.
    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. Keep out of reach of children. Federal law requires that this container be filled with oxygen USP only by establishments registered as a drug manufacturer in accordance with the Federal Food, Drug, and Cosmetic Act.
    DANGER: MAY CAUSE OR INTENSIFY FIRE; OXYDIZER. CONTAINS REFRIGERATED GAS; MAY CAUSE CRYOGENIC BURNS OR INJURY. COMBUSTIBLES IN CONTACT WITH LIQUID OXYGEN MAY EXPLODE ON IGNITION OR IMPACT. Do not handle until all safety precautions have been read and understood. Keep and store away from clothing and other combustible materials. Keep valves and fittings free from grease and oil. Use and store only outdoors or in a well-ventilated place. Wear cold insulating gloves, face shield, and eye protection. In case of fire; Stop leak if safe to do so. Use a back flow preventive device in the piping. Use only with equipment of compatible materials of construction and rated for cylinder pressure. Use only with equipment cleaned for oxygen service. DO NOT change or force fit connections. Avoid spills, Do not walk on or roll equipment over spills. Close valve after each use and when empty. Always keep container in upright position. Read and follow the Safety Data Sheet (SDS) before use.
    FIRST AID: IF ON SKIN: Thaw frosted parts with lukewarm water. Do not rub affected area. Get immediate medical advice/attention. CAS: 7782-44-7
    HAUN COMPANIES 5921 COURT STREET ROAD . SYRACUSE, NY 13206 315-463-5241 oxygen three

  • INGREDIENTS AND APPEARANCE
    OXYGEN 
    oxygen gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:14961-001
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN990 L  in 1 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14961-001-0137 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/2005
    2NDC:14961-001-02103 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/2005
    3NDC:14961-001-03150 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/2005
    4NDC:14961-001-04171 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/2005
    5NDC:14961-001-05210 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/2005
    6NDC:14961-001-06248 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/2005
    7NDC:14961-001-07415 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/2005
    8NDC:14961-001-08588 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/2005
    9NDC:14961-001-09682 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/2005
    10NDC:14961-001-101724 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/2005
    11NDC:14961-001-113452 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/2005
    12NDC:14961-001-127507 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/2005
    13NDC:14961-001-13212 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/2005
    14NDC:14961-001-14424 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/2005
    15NDC:14961-001-15691 L in 1 CYLINDER; Type 1: Convenience Kit of Co-Package01/01/2005
    16NDC:14961-001-162678 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/2005
    17NDC:14961-001-173606 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/2005
    18NDC:14961-001-186999 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/2005
    19NDC:14961-001-199427 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/2005
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20576701/01/2005
    Labeler - Haun Specialty Gases, Inc. (174193784)
    Establishment
    NameAddressID/FEIBusiness Operations
    Haun Specialty Gases, Inc.174193784manufacture(14961-001)

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