HELIUM OXYGEN MIX - helium oxygen mix gas 
Encompass Medical & Specialty Gases Ltd

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.

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Helium Oxygen Mix Label

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.Helium Oxygen Mix Label

HELIUM OXYGEN MIX 
helium oxygen mix gas
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:48883-007
Route of AdministrationRESPIRATORY (INHALATION)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Helium (UNII: 206GF3GB41) (Helium - UNII:206GF3GB41) Helium500 mL  in 1 L
Oxygen (UNII: S88TT14065) (Oxygen - UNII:S88TT14065) Oxygen500 mL  in 1 L
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:48883-007-01617 L in 1 CYLINDER
2NDC:48883-007-02623 L in 1 CYLINDER
3NDC:48883-007-03629 L in 1 CYLINDER
4NDC:48883-007-04640 L in 1 CYLINDER
5NDC:48883-007-05654 L in 1 CYLINDER
6NDC:48883-007-065689 L in 1 CYLINDER
7NDC:48883-007-075743 L in 1 CYLINDER
8NDC:48883-007-085796 L in 1 CYLINDER
9NDC:48883-007-095904 L in 1 CYLINDER
10NDC:48883-007-106009 L in 1 CYLINDER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved medical gas04/15/2009
Labeler - Encompass Medical & Specialty Gases Ltd (963344143)
Establishment
NameAddressID/FEIBusiness Operations
Encompass Medical & Specialty Gases Ltd963344143manufacture
Establishment
NameAddressID/FEIBusiness Operations
Encompass Medical & Specialty Gases Ltd963719286manufacture
Establishment
NameAddressID/FEIBusiness Operations
Encompass Medical & Specialty Gases Ltd963719096manufacture
Establishment
NameAddressID/FEIBusiness Operations
Encompass Medical & Specialty Gases Ltd963718361manufacture

Revised: 12/2011
Document Id: 7f1be800-2f65-44ac-b6fa-df6904a1b0ec
Set id: 298bce73-9e59-40e1-ad71-97b2db89b696
Version: 3
Effective Time: 20111229
 
Encompass Medical & Specialty Gases Ltd