Label: COMPRESSED, N.O.S.- helium, oxygen gas
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Contains inactivated NDC Code(s)
NDC Code(s): 25373-012-01, 25373-012-02, 25373-012-03, 25373-012-04, view more25373-012-05 - Packager: Linde Gas & Equipment Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved medical gas
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Drug Label Information
Updated December 14, 2021
If you are a consumer or patient please visit this version.
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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.
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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
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INGREDIENTS AND APPEARANCE
COMPRESSED, N.O.S.
helium, oxygen gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:25373-012 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Helium (UNII: 206GF3GB41) (Helium - UNII:206GF3GB41) Helium 79 L in 100 L Oxygen (UNII: S88TT14065) (Oxygen - UNII:S88TT14065) Oxygen 21 L in 100 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:25373-012-01 300 L in 1 CYLINDER; Type 0: Not a Combination Product 06/24/1998 2 NDC:25373-012-02 500 L in 1 CYLINDER; Type 0: Not a Combination Product 06/24/1998 3 NDC:25373-012-03 2260 L in 1 CYLINDER; Type 0: Not a Combination Product 06/24/1998 4 NDC:25373-012-04 4000 L in 1 CYLINDER; Type 0: Not a Combination Product 06/24/1998 5 NDC:25373-012-05 4500 L in 1 CYLINDER; Type 0: Not a Combination Product 06/24/1998 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved medical gas 06/24/1998 Labeler - Linde Gas & Equipment Inc. (805568339) Registrant - Linde Gas & Equipment Inc. (805568339) Establishment Name Address ID/FEI Business Operations Linde Gas & Equipment Inc. 010263301 manufacture(25373-012) Establishment Name Address ID/FEI Business Operations Linde Gas & Equipment Inc. 016271697 manufacture(25373-012)