OXYGEN GAS [TWO MP INVESTMENTS, INC. DBA RESPICARE]

OXYGEN GAS [TWO MP INVESTMENTS, INC. DBA RESPICARE]
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NDC 67152-001-01, 67152-001-02, 67152-001-03, 67152-001-04, 67152-001-05
Set ID 9a7570dc-2ed9-4f67-b80d-3fb132598da5
Category HUMAN PRESCRIPTION DRUG LABEL
Packager Two MP Investments, Inc. dba Respicare
Generic Name
Product Class
Product Number
Application Number
  • PACKAGE LABEL PRINCIPAL DISPLAY PANEL

    Produced by air liquefaction

    OXYGEN
    COMPRESSED
    U.S.P. UN 1072

    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 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 Food, Drug and Cosmetic Act.
    • Pursuant to recommendation by Compressed Gas Association (CGA C-7-2000), do not expose pressurized cylinders to temperatures in excess of 125 F.
    • DO NOT REMOVE THIS PRODUCT LABEL.
    use only in accordance with product instructions and material safety data sheet.

    Distributed by:
    Respicare
    Home Respiratory Care
    7411 Alban Station Court,
    Suite A100
    Springfield, Virginia 22150
    (703) 440-3600
    (800) 881-9207

    WARNING:
    HIGH PRESSURE GAS CYLINDER


    Improper filling or abuse of this cylinder, or failure to heed this warning may cause serious injury or loss of life. DO NOT ALTER OR MODIFY CYLINDER OR RELATED COMPONENTS. DO NOT OVER PRESSURIZE. Keep out of reach of children. Cylinders that have been refinished and/or exposed to elevated temperatures must be hydrostatically tested before filling. do not use caustic paint strippers. Aluminum cylinders subject to action of fire or heated to temperatures in excess of 350 F must be withdrawn from service and condemned. Valves and safety relief devices must be removed and replaced by trained personnel. Do not alter or change safety discs. Replace pressure relief devices only with complete assemblies supplied by the valve manufacturer. DO NOT FILL WITH OXIDIZING GASES WITHOUT PROPER CLEANING. Cylinders, valves, and assemblies must be specially cleaned for oxygen. Verify cylinder content and monthly, or more frequently if required. Store and use with adequate ventilation.
    Oxygen Compressed Label
  • INGREDIENTS AND APPEARANCE
    OXYGEN 
    oxygen gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:67152-001
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN1 L  in 1 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67152-001-01685 L in 1 CYLINDER
    2NDC:67152-001-02416 L in 1 CYLINDER
    3NDC:67152-001-03249 L in 1 CYLINDER
    4NDC:67152-001-04165 L in 1 CYLINDER
    5NDC:67152-001-05114 L in 1 CYLINDER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved medical gas10/28/2010
    Labeler - Two MP Investments, Inc. dba Respicare (132283925)
    Establishment
    NameAddressID/FEIBusiness Operations
    Two MP Investments, Inc. dba Respicare132283925manufacture

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