RECONSTITUTED AIR GAS [AMERICAN WELDING & GAS, INC.]

RECONSTITUTED AIR GAS [AMERICAN WELDING & GAS, INC.]
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NDC 52346-005-01, 52346-005-02, 52346-005-03
Set ID 83d44263-d000-a5d0-e053-2a91aa0a218b
Category HUMAN PRESCRIPTION DRUG LABEL
Packager AMERICAN WELDING & GAS, INC.
Generic Name
Product Class
Product Number
Application Number NDA205865
  • PRINCIPAL DISPLAY PANEL

    AIR, COMPRESSED

    UN1002

    MEDICAL AIR, USP

    WARNING: For breathing support when used by properly trained personnel. For medical applications, RX only. Administration of Medical Air 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 Medical Air 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. WARNING: CONTAINS GAS UNDER PRESSURE: MAY EXPLODE IF HEATED. SUPPORTS COMBUSTION. Do not handle until all safety precautions have been read and understood. Use a back flow preventive device in the piping. Mixture of oxygen USP and nitrogen NF. Use only equipment of compatible materials of construction and rated for cylinder pressure. 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: 132259-10-0 DO NOT REMOVE THIS PRODUCT LABEL.

    American Welding & Gas, Inc.

    4900 Falls of Neuse Road, Suite 150

    Raleigh, NC 27609

    800-967-6874 air

  • INGREDIENTS AND APPEARANCE
    RECONSTITUTED AIR 
    reconstituted air gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:52346-005
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN210 mL  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    NITROGEN (UNII: N762921K75) 790 mL  in 1 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52346-005-018807 L in 1 CYLINDER; Type 0: Not a Combination Product02/13/2019
    2NDC:52346-005-026598 L in 1 CYLINDER; Type 0: Not a Combination Product02/13/2019
    3NDC:52346-005-03665 L in 1 CYLINDER; Type 0: Not a Combination Product02/13/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20586502/13/2019
    Labeler - AMERICAN WELDING & GAS, INC. (868040283)
    Establishment
    NameAddressID/FEIBusiness Operations
    AMERICAN WELDING & GAS, INC.116724243manufacture(52346-005)
    Establishment
    NameAddressID/FEIBusiness Operations
    AMERICAN WELDING & GAS, INC.116933887manufacture(52346-005)

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