Country: United States
Language: English
Source: NLM (National Library of Medicine)
AIR (UNII: K21NZZ5Y0B) (AIR - UNII:K21NZZ5Y0B)
DuPuy Oxygen & Supply Company, Inc.
RESPIRATORY (INHALATION)
PRESCRIPTION DRUG
New Drug Application
AIR- AIR GAS DUPUY OXYGEN & SUPPLY COMPANY, INC. ---------- AIR Air, Compressed UN1002 Non-flammable gas, 2 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. Use only with 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 Degrees Celsius (125 Degrees Fahrenheit). Read and follow the Safety Data Sheet (SDS) before use. CAS 132259-10-0 DO NOT REMOVE THIS PRODUCT LABEL. DuPuy Oxygen & Supply 7201 Imperial Drive Waco, TX 76712 254-772-3460 AIR air gas PRODUCT INFORMATION DuPuy Oxygen & Supply Company, Inc. PRODUCT TYPE HUMAN PRESCRIPTION DRUG ITEM CODE (SOURCE) NDC:50554-007 ROUTE OF ADMINISTRATION RESPIRATORY (INHALATION) ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH AIR (UNII: K21NZZ5Y0B) (AIR - UNII:K21NZZ5Y0B) AIR 1000 mL in 1 L PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:50554- 007-01 708 L in 1 CYLINDER; Type 0: Not a Combination Product 01/13/2014 2 NDC:50554- 007-02 6570 L in 1 CYLINDER; Type 0: Not a Combination Product 01/13/2014 MARKETING INFORMATION MARKETING CATEGORY APPLICATION NUMBER OR MONOGRAPH CITATION MARKETING START DATE MARKETING END DATE NDA NDA205826 01/13/2014 LABELER - DuPuy Oxygen & Supply Company, Inc. (027189646) ESTABLI Read the complete document