OXYGEN GAS [FLORIDA PALLIATIVE EQUIPMENT L.L.C. DBA ACCENT MEDICAL]

OXYGEN GAS [FLORIDA PALLIATIVE EQUIPMENT L.L.C. DBA ACCENT MEDICAL]
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NDC 61580-123-01, 61580-123-02, 61580-123-03, 61580-123-04
Set ID 7b316f95-e3a1-43aa-e053-2991aa0a8484
Category HUMAN PRESCRIPTION DRUG LABEL
Packager Florida Palliative Equipment L.L.C. dba Accent Medical
Generic Name
Product Class
Product Number
Application Number
  • Principal for Oxygen Product

    RepresentativeLotSticker

    HPLabel

    OXYGEN

    COMPRESSED

    USP

    UN 1072

    DANGER:

    MAY CAUSE OR INTENSIFY FIRE; OXIDIZER. 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 NO: 7782-44-7

    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. Produced by Air Liquefaction.

    Federal Law Requires that this Container be Refilled with Oxygen U.S.P. Only by Establishments Registered as a Drug Producer in accordance with the Federal Food, Drug and Cosmetic Act. Warning — uninterrupted use of high concentrations of oxygen for more than five hours 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. Contents under high pressure and can vigorously accelerate combustion. Keep free from oil and grease. Do not use or store near heat or open flame and use only with equipment conditioned for oxygen service.

  • INGREDIENTS AND APPEARANCE
    OXYGEN 
    oxygen gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:61580-123
    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:61580-123-02255 L in 1 CYLINDER; Type 0: Not a Combination Product01/19/2012
    2NDC:61580-123-03425 L in 1 CYLINDER; Type 0: Not a Combination Product01/19/2012
    3NDC:61580-123-01164 L in 1 CYLINDER; Type 0: Not a Combination Product01/19/2012
    4NDC:61580-123-04680 L in 1 CYLINDER; Type 0: Not a Combination Product01/19/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved medical gas01/19/2012
    Labeler - Florida Palliative Equipment L.L.C. dba Accent Medical (013070819)
    Establishment
    NameAddressID/FEIBusiness Operations
    Florida Palliative Equipment L.L.C. dba Accent Medical 013070819manufacture(61580-123)

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