Label: OXYGEN gas
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Contains inactivated NDC Code(s)
NDC Code(s): 49121-001-01, 49121-001-02, 49121-001-03, 49121-001-04 - Packager: Global Medical LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated December 15, 2020
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Oxygen Compressed USP Label
OXYGEN COMPRESSED USP UN 1072 OXYGEN 2
C.A.S. NO. 7782-44-7 GlobalMedical 8332 Bristol Ct. Suite 108 Jessup, MD 20794 800-528-1001
WARNING: HIGH PRESSURE OXIDIZING GAS. VIGOROUSLY ACCELERATES COMBUSTION. NO SMOKING IN THE PRESENCE OF OXYGEN OR A FIRE MAY RESULT.
KEEP OIL AND GREASE AWAY. OPEN VALVE SLOWLY. STORE AND USE WITH ADEQUATE VENTILATION. USE ONLY WITH EQUIPMENT CLEANED FOR OXYGEN SERVICE AND RATED FOR CYLINDER PRESSURE.
USE A BACK FLOW PREVENTATIVE DEVICE IN THE PIPING.
CLOSE VALVE AFTER EACH USE AND WHEN EMPTY. CYLINDER TEMPERATURE SHOULD NOT EXCEED 52 C (125 F)
USE IN ACCORDANCE WITH THE MATERIAL SAFETY DATA SHEET (MSDS)
DO NOT REMOVE THIS PRODUCT LABEL.
WARNING: FOR EMERGENCY USE ONLY WHEN ADMINISTERED BY PROPERLY TRAINED PERSONNEL FOR OXYGEN DEFICIENCY AND RESUSCITATION. FOR ALL OTHER MEDICAL APPLICATIONS Rx ONLY. UNINTERRUPTED USE OF HIGH CONCENTRATIONS OF OXYGEN OVER A LONG DURATION WITHOUT MONITORING ITS EFFECT ON OXYGEN CONTENT OF ARTERIAL BLOOD MAY BE HARMFUL. USE ONLY WITH PRESSURE REDUCING EQUIPMENT AND APPARATUS DESIGNED FOR OXYGEN. DO NOT ATTEMPT TO USE ON PATIENTS WHO HAVE STOPPED BREATHING UNLESS USED IN CONJUNCTION WITH RESUSCITATIVE EQUIPMENT.
PRODUCED BY AIR LIQUEFACTION.
Size Contents
M6 170 Liters
C 248 Liters
D 415 Liters
E 682 Liters
H 6910 Liters
Other ______ Liters
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INGREDIENTS AND APPEARANCE
OXYGEN
oxygen gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49121-001 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN 99 L in 100 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49121-001-01 170 L in 1 CYLINDER; Type 0: Not a Combination Product 04/01/2012 2 NDC:49121-001-02 415 L in 1 CYLINDER; Type 0: Not a Combination Product 04/01/2012 3 NDC:49121-001-03 682 L in 1 CYLINDER; Type 0: Not a Combination Product 04/01/2012 4 NDC:49121-001-04 1724 L in 1 CYLINDER; Type 0: Not a Combination Product 04/01/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA206023 04/01/2012 Labeler - Global Medical LLC (167933303) Registrant - Global Medical LLC (167933303) Establishment Name Address ID/FEI Business Operations Global Medical LLC 167933303 manufacture(49121-001)