Label: MEDICAL AIR- air gas
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Contains inactivated NDC Code(s)
NDC Code(s): 48273-007-01, 48273-007-02, 48273-007-03, 48273-007-04, view more48273-007-05 - Packager: Keen Compressed Gas Co. Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated October 25, 2018
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AIR COMPRESSED USP LABEL
KEEN
AIR, COMPRESSED USP UN1002
DO NOT REMOVE THIS LABEL
36300-01-15 MADE IN THE USA
NON-FLAMMABLE GAS
MEDICAL AIR, U.S.P.
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 backflow preventive device I 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°C (125°F). Read and follow the Safety Data Sheet (SDS) before use.
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.
DO NOT REMOVE THIS PRODUCT LABEL
RETURN WITH 25 PSIG
FILLED & DISTRIBUTED BY:
KEEN COMPRESSED GAS CO.
4063 NEW CASTLE AVE.
NEW CASTELE, de 19720 • (302) 594-4545
Pressure: PSIG at 70OF
Size
Contents liters
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INGREDIENTS AND APPEARANCE
MEDICAL AIR
air gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:48273-007 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN 21 L in 100 L Inactive Ingredients Ingredient Name Strength NITROGEN (UNII: N762921K75) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:48273-007-01 385 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1919 2 NDC:48273-007-02 625 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1919 3 NDC:48273-007-03 3310 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1919 4 NDC:48273-007-04 6620 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1919 5 NDC:48273-007-05 8800 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1919 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA206023 01/01/1919 Labeler - Keen Compressed Gas Co. Inc. (002484723) Registrant - Keen Compressed Gas Co. Inc. (002484723) Establishment Name Address ID/FEI Business Operations Keen Compressed Gas Co. Inc. 617860770 manufacture(48273-007)