OXYGEN GAS [HEART OF THE OZARKS MEDICAL EQUIPMENT]

OXYGEN GAS [HEART OF THE OZARKS MEDICAL EQUIPMENT]
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NDC 54832-0001-1, 54832-0001-2, 54832-0001-3, 54832-0001-4, 54832-0001-5, 54832-0001-6, 54832-0001-7, 54832-0001-8
Set ID 4fd4b894-934a-4595-ba2f-94b8d2f36acf
Category HUMAN PRESCRIPTION DRUG LABEL
Packager Heart of the Ozarks Medical Equipment
Generic Name
Product Class
Product Number
Application Number
  • Principal for Oxygen Product

    Representative Label

    OXYGEN

    COMPRESSED

    USP

    UN 1072

    PRODUCED BY AIR LIQUIFICATION

    WARNING: HIGH PRESSURE OXIDIZING GAS, VIGOROUSLY ACCELERATES COMBUSTION. NO SMOKING IN THE PRESENCE OF OXYGEN OR A FIRE MAY RESULT.

    WARNING: For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx only.

    WARNING: Federal law prohibits dispensing without prescription. 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 oxygen. Do not attempt to use on patients who have stopped breathing, unless used in conjuction with resuscitative equipment.

    WARNING: Keep oil and grease away. Use only with equipment cleaned for oxygen service and rated for cylinder pressure. Open valve slowly. Close valve after each use and when empty.

    USE IN ACCORDANCE WITH MATERIAL SAFETY DATA SHEET.

    DO NOT REMOVE THIS PRODUCT LABEL.

    RespresentativeLoxLabel

    OXYGEN,

    REFRIGERATED

    LIQUID USP

    UN 1073

    CONTENTS ________________LITERS

    CAS NO: 7782-44-7

    DANGER:

    REFRIGERATED LIQUEFIED OXIDIZING GAS. ALWAYS

    KEEP CONTAINER IN UPRIGHT POSITION. DO NOT

    CHANGE OR FORCE FIT CONNECTIONS. MAY CAUSE OR INTENSIFY

    FIRE; OXIDIZER, CONTAINS REFRIGERATED GAS: MAY CAUSE

    CRYOGENIC BURNS OR INJURY. COMBUSTIBLES IN CONTACT WITH

    LIQUID OXYGEN MAY EXPLODE ON IGNITION OR IMPACT.

    Do not get in eyes, on skin, or on clothing. Keep reduction valves free

    from grease and oil. In case of fire, stop leak if safe to do so. Avoid

    spills. Do not walk or roll equipment over spills. Store and use in a well

    ventilated place. Use only with equipment of compatible materials

    of construction and rated for cylinder pressure. Wear cold insulating

    gloves/face shield/eye protection. Protect from sunlight when ambient

    temperature exceeds 52 F. Container temperature should

    not exceed 52 F. Close valve after each use and when

    empty. Use a back flow preventative device in the piping. Do not

    handle until all safety precautions have been read and understood.

    Use only with equipment cleaned for oxygen service. Keep/store away

    from combustible materials. Do not drop. Use suitable hand truck for

    container movement.

    FIRST AID:

    IN CASE OF FROSTBITE: Thaw frosted parts with lukewarm water.

    Do not rub affected area. Get immediate medical advice/attention.

    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 of 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 resuscitative equipment. Produced by Air Liquefaction.

    ALWAYS KEEP CONTAINER IN UPRIGHT POSITION

    RepresentativeLotSticker

  • INGREDIENTS AND APPEARANCE
    OXYGEN 
    oxygen gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:54832-0001
    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:54832-0001-2255 L in 1 CYLINDER; Type 0: Not a Combination Product12/02/2009
    2NDC:54832-0001-3396 L in 1 CYLINDER; Type 0: Not a Combination Product12/02/2009
    3NDC:54832-0001-1181 L in 1 CYLINDER; Type 0: Not a Combination Product12/02/2009
    4NDC:54832-0001-4679 L in 1 CYLINDER; Type 0: Not a Combination Product12/02/2009
    5NDC:54832-0001-51732 L in 1 CYLINDER; Type 0: Not a Combination Product12/02/2009
    6NDC:54832-0001-741 L in 1 DEWAR; Type 0: Not a Combination Product12/02/2009
    7NDC:54832-0001-846 L in 1 DEWAR; Type 0: Not a Combination Product12/02/2009
    8NDC:54832-0001-03455 L in 1 CYLINDER; Type 0: Not a Combination Product12/02/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved medical gas12/02/2009
    Labeler - Heart of the Ozarks Medical Equipment (180208464)
    Establishment
    NameAddressID/FEIBusiness Operations
    Heart of the Ozarks Medical Equipment180208464manufacture(54832-0001)

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