Heliox: Package Insert and Label Information

HELIOX — oxygen and helium gas
Spec Connection International Inc

OXYGEN 2 NON-FLAMMABLE GAS 2 Compressed Gas, oxidizing, n.o.s. (Oxygen, Helium) UN3156 Medical Gas Mixture 25% Oxygen, USP CAS: 7782-44-7 Balance Helium, USP CAS: 7740-59-7 CAUTION: Federal law prohibits dispensing without a prescription. Rx Only. WARNING: OXIDIZING HIGH PRESSURE GAS. VIGOROUSLY ACCELERATES COMBUSTION. Keep oil and grease away. Use only with equipment cleaned for oxygen service and rated for cylinder pressure. Use equipment rated for cylinde pressure. Store and use with adequate ventilation. Close valve after each use and when empty. Open valve slowly. Administration of this gas mixture may be hazardous or contraindicated. For use only by or under the 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. Use in accordance with the appropriate MSDS for each mixture component. Secure cylinder while in transportation, storage, and in use. Serial Number: 283751 In Emergency Call: 1-800-494-9300 Lot No: 338sci12dp1 Volume 25 Exp Date: 12/11/17 Label #: RG101 December 12, 2012 Ver 2.33 For Medical Use Only. Spec Connection International Inc 37325 sr 54 Zephyrhills, FL 33542 Ph# 813-997-8950
heliox one
(click image for full-size original)
HELIOX
heliox gas
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54776-001
Route of Administration RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Oxygen (Oxygen) Oxygen 300 mL in 1 L
Helium (Helium) Helium 700 mL in 1 L
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54776-001-01 707 L in 1 CYLINDER None
2 NDC:54776-001-02 5663 L in 1 CYLINDER None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved medical gas 01/01/2013
Labeler — Spec Connection International Inc (059854468)
Establishment
Name Address ID/FEI Operations
Spec Connection International, Inc. 026151816 manufacture (54776-001)

Revised: 12/2012 Spec Connection International Inc

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