Label: HELIUM OXYGEN MIX gas
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Contains inactivated NDC Code(s)
NDC Code(s): 48883-007-01, 48883-007-02, 48883-007-03, 48883-007-04, view more48883-007-05, 48883-007-06, 48883-007-07, 48883-007-08, 48883-007-09, 48883-007-10 - Packager: Encompass Medical & Specialty Gases Ltd
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved medical gas
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Drug Label Information
Updated December 29, 2011
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PRINCIPAL DISPLAY PANEL
COMPRESSED GAS , OXIDIZING, N.O.S. (70% HELIUM USP, 30% OXYGEN USP) UN 3156
NON-FLAMMABLE GAS 2 OXIDIZER 5.1
34313 (01/09) OXYGEN CONTENT OVER 23.5%
Rx only. CAUTION: Federal law prohibits dispensing without prescription. WARNING: Administration of this gas may be hazardous or contraindicated. For use only by or under 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. WARNING: HIGH PRESSURE OXIDIZING GAS. MAY VIGOROUSLY ACCELERATE COMBUSTION. Store and use with adequate ventilation. Keep oil and grease away. Use only with equipment cleaned for oxygen service and rated for cylinder pressure. Use a back flow preventive device in the piping. Cylinder temperatures should not exceed 52C (125F). Open valve slowly. Close valve after each use and when empty. Use in accordance with the Material Safety Data Sheet (MSDS). FIRST AID: IF INHALED, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Call a physician. HELIUM CAS: 7440-59-7 OXYGEN CAS: 7782-44-7
DO NOT REMOVE THIS PRODUCT LABEL.
Cylinders must be refilled by:
Encompass Medical and Specialty Gases, LTD. 4646 Linden Road P.O. Box 5404 Rockford, IL 61109
CONTENTS: LTRS CU. FT.
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INGREDIENTS AND APPEARANCE
HELIUM OXYGEN MIX
helium oxygen mix gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:48883-007 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Helium (UNII: 206GF3GB41) (Helium - UNII:206GF3GB41) Helium 500 mL in 1 L Oxygen (UNII: S88TT14065) (Oxygen - UNII:S88TT14065) Oxygen 500 mL in 1 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:48883-007-01 617 L in 1 CYLINDER 2 NDC:48883-007-02 623 L in 1 CYLINDER 3 NDC:48883-007-03 629 L in 1 CYLINDER 4 NDC:48883-007-04 640 L in 1 CYLINDER 5 NDC:48883-007-05 654 L in 1 CYLINDER 6 NDC:48883-007-06 5689 L in 1 CYLINDER 7 NDC:48883-007-07 5743 L in 1 CYLINDER 8 NDC:48883-007-08 5796 L in 1 CYLINDER 9 NDC:48883-007-09 5904 L in 1 CYLINDER 10 NDC:48883-007-10 6009 L in 1 CYLINDER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved medical gas 04/15/2009 Labeler - Encompass Medical & Specialty Gases Ltd (963344143) Establishment Name Address ID/FEI Business Operations Encompass Medical & Specialty Gases Ltd 963344143 manufacture Establishment Name Address ID/FEI Business Operations Encompass Medical & Specialty Gases Ltd 963719286 manufacture Establishment Name Address ID/FEI Business Operations Encompass Medical & Specialty Gases Ltd 963719096 manufacture Establishment Name Address ID/FEI Business Operations Encompass Medical & Specialty Gases Ltd 963718361 manufacture