Label: CARBON DIOXIDE AND OXYGEN MIXTURE, COMPRESSED, OXIDIZING, N.O.S.- oxygen, carbon dioxide gas

  • NDC Code(s): 25373-011-05, 25373-011-06, 25373-011-07, 25373-011-08, view more
    25373-011-09
  • Packager: Linde Gas North America LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved medical gas

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated October 1, 2018

If you are a consumer or patient please visit this version.

  • WARNINGS AND PRECAUTIONS SECTION

    WARNING: Administration of this 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: MAY CAUSE OR INTENSIFY FIRE; OXIDIZER. CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED. MAY INCREASE RESPIRATION AND HEART RATE. 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. In case of fire: Stop leak if safe to do so. 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.

    FIRST AID: IF ACCIDENTLY INHALED: Remove person to fresh air and keep comfortable breathing. Get medical advice/attention.

  •       

    CO2-O2 Mix Label

    Linde

    COMPRESSED GAS, OXIDIZING, N.O.S.
    (CARBON DIOXIDE, OXYGEN)

    UN3156
    CAS 124-38-9
    CAS 7782-44-7

     2

      5.1

    Rx only
    MEDICAL GAS

    _______% CARBON DIOXIDE USP
    _______% OXYGEN USP
    MIXTURE (NOT FOR CALIBRATION PURPOSES)

    FOR MIXTURES GREATER THAN 23.5% OXYGEN.
    Component concentrations in mol%.*


    _________________ PSI @ 70°F _________________ LITERS


     



    DO NOT REMOVE THIS PRODUCT LABEL.

    Linde Gas North America LLC
    200 Somerset Corporate Blvd., Suite 7000
    Bridgewater, NJ 08807
    866.543.3427

    SGM001G

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

  • INGREDIENTS AND APPEARANCE
    CARBON DIOXIDE AND OXYGEN MIXTURE, COMPRESSED, OXIDIZING, N.O.S.  
    oxygen, carbon dioxide gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:25373-011
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Oxygen (UNII: S88TT14065) (Oxygen - UNII:S88TT14065) Oxygen95 L  in 100 L
    Carbon Dioxide (UNII: 142M471B3J) (Carbon Dioxide - UNII:142M471B3J) Carbon Dioxide5 L  in 100 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:25373-011-06400 L in 1 CYLINDER; Type 6: Drug/Biologic Combination06/24/1998
    2NDC:25373-011-07660 L in 1 CYLINDER; Type 6: Drug/Biologic Combination06/24/1998
    3NDC:25373-011-086000 L in 1 CYLINDER; Type 6: Drug/Biologic Combination06/24/1998
    4NDC:25373-011-093000 L in 1 CYLINDER; Type 6: Drug/Biologic Combination06/24/1998
    5NDC:25373-011-055300 L in 1 CYLINDER; Type 6: Drug/Biologic Combination06/24/1998
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved medical gas06/24/1998
    Labeler - Linde Gas North America LLC (805568339)
    Establishment
    NameAddressID/FEIBusiness Operations
    Linde Gas North America LLC010263301MANUFACTURE(25373-011)
    Establishment
    NameAddressID/FEIBusiness Operations
    Linde Gas North America LLC016271697manufacture(25373-011)