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Compressed Gas N.O.S.: Package Insert / Prescribing Info

Package insert / product label
Generic name: oxygen, helium
Dosage form: gas

Warnings and Precautions

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.

Helium-Oxygen Mix Label 1

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 TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:25373-012
Route of AdministrationRESPIRATORY (INHALATION)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Helium (UNII: 206GF3GB41) (Helium - UNII:206GF3GB41) Helium79 L in 100 L
Oxygen (UNII: S88TT14065) (Oxygen - UNII:S88TT14065) Oxygen21 L in 100 L
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:25373-012-01300 L in 1 CYLINDER; Type 0: Not a Combination Product06/24/1998
2NDC:25373-012-02500 L in 1 CYLINDER; Type 0: Not a Combination Product06/24/1998
3NDC:25373-012-032260 L in 1 CYLINDER; Type 0: Not a Combination Product06/24/1998
4NDC:25373-012-044000 L in 1 CYLINDER; Type 0: Not a Combination Product06/24/1998
5NDC:25373-012-054500 L in 1 CYLINDER; Type 0: Not a Combination Product06/24/1998
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved medical gas06/24/1998
Labeler - Linde Gas & Equipment Inc. (805568339)
Registrant - Linde Gas & Equipment Inc. (805568339)
Establishment
NameAddressID/FEIBusiness Operations
Linde Gas & Equipment Inc.010263301manufacture(25373-012)
Establishment
NameAddressID/FEIBusiness Operations
Linde Gas & Equipment Inc.016271697manufacture(25373-012)