HYPERBARIC CHAMBER MIX GAS [SPEC CONNECTION INTERNATIONAL INC]

HYPERBARIC CHAMBER MIX GAS [SPEC CONNECTION INTERNATIONAL INC]
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NDC 54776-005-01
Set ID 6141a28d-8335-8aa8-e053-2a91aa0a197e
Category HUMAN PRESCRIPTION DRUG LABEL
Packager Spec Connection International Inc
Generic Name
Product Class
Product Number
Application Number NDA205889
  • PRINCIPAL DISPLAY PANEL

    NON-FLAMMABLE 2 OXYGEN 2 Compressed gas, oxidizing, n.o.s. (Oxygen, Nitrogen) UN3156 Medical Gas Mixture 50% Oxygen, USP CAS: 7782-44-7 Balance Nitrogen, USP CAS: 7727-37-9 Rx only WARNING: Administration of this gas mixture may be hazardous or contraindicated. For use only by or under the supervision of a licensed practitioner who is experienced in the use and administration of gas mixtures and is familiar with the indications, effects, dosages, methods, and frequency and duration of administration, and with the hazards, contraindications and side effects, and the precautions to be taken. DANGER: CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED MAY CAUSE OR INTENSIFY FIRE; OXIDIZER.
    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. 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 degrees C (125 degrees F). Read and follow the Safety Data Sheet (SDS) before use.
    FIRST AID: IF ACCIDENTALLY INHALED: Remove person to fresh air and keep comfortable for breathing. Get medical advice/attention.
    DO NOT REMOVE THIS PRODUCT LABEL. For Medical Use Only.
    SPEC CONNECTION INTERNALTIONAL, INC. 37325 STATE ROAD 54. ZEPHYRHILLS, FL 33542 813-997-7646 hyberbaric

  • INGREDIENTS AND APPEARANCE
    HYPERBARIC CHAMBER MIX 
    hyperbaric chamber mix gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:54776-005
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN500 mL  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    NITROGEN (UNII: N762921K75) 500 mL  in 1 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54776-005-015663 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20588901/01/2013
    Labeler - Spec Connection International Inc (059854468)
    Establishment
    NameAddressID/FEIBusiness Operations
    Spec Connection International, Inc.026151816manufacture(54776-005)

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