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Compressed Gas N.O.S.

Generic Name: oxygen, helium
Dosage Form: gas

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA.

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WARNINGS AND PRECAUTIONS SECTION

WARNING:
Administration of this mixture may be hazardout or contraindicated. For use only by or under the supervision of a licensed practitioner who is experienced in the use and administration of Helium/Oxygen Mixtrues, who is familiar with the indications, effects, dosages, methods, frequency, and duration of administration and with the hazards, contraindications, side effects, and precations to be taken.


WARNING: CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED.

Do not handle until all safety precautions have been read and understood.
Use and store only outdoors or in a well ventilated place.
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°C (125°F).
Read and follow the Safety Data Sheet (SDS) before use.

FIRST AID:
IF ACCIDENTALLY INHALED:
Remove person to fresh air and keep comfortable for breathing. Get medical advice/attention.

             

Linde

COMPRESSED GAS, N.O.S.

(Helium, Oxygen)

UN1956
CAS 7440-59-7
CAS 7782-44-7

2
MEDICAL GAS

_______ % HELIUM USP
_______ % OXYGEN USP
MIXTURE (NOT FOR CALIBRATION PURPOSES)
Component concentrations in mol%.
NOT FOR MIXTURES EQUAL TO OR GREATER THAN 23.5% OXYGEN.

_________________ PSI @ 70°F _________________ LITERS

Rx only

DO NOT REMOVE THIS PRODUCT LABEL.

Distributed by:
Linde Gas North America LLC
200 Somerset Corporate Blvd., Suite 7000
Bridgewater, NJ 08807
866.543.3427

MG806N

COMPRESSED, N.O.S.  
helium, oxygen gas
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:25373-012
Route of Administration RESPIRATORY (INHALATION) DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Helium (Helium) Helium 79 L  in 100 L
Oxygen (Oxygen) Oxygen 21 L  in 100 L
Packaging
# Item Code Package Description
1 NDC:25373-012-01 300 L in 1 CYLINDER
2 NDC:25373-012-02 500 L in 1 CYLINDER
3 NDC:25373-012-03 2260 L in 1 CYLINDER
4 NDC:25373-012-04 4000 L in 1 CYLINDER
5 NDC:25373-012-05 4500 L in 1 CYLINDER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved medical gas 06/24/1998
Labeler - Linde Gas North America LLC (805568339)
Registrant - Linde Gas North America LLC (805568339)
Establishment
Name Address ID/FEI Operations
Linde Gas North America LLC 010263301 MANUFACTURE(25373-012)
Establishment
Name Address ID/FEI Operations
Linde Gas North America LLC 016271697 manufacture(25373-012)
Revised: 11/2017
 
Linde Gas North America LLC
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