Nitric Oxide Nitrogen Mix

Dosage Form: gas
Nitric Oxide Nitrogen Mix

CareFusion

ViaNOx-H 5000ppm   Nitric Oxide 5000ppm (0.5% v/v)

CAUTION: Contains a New Drug – Limited by Federal Law (USA) to Investigational Use Only

Compressed Gases, N.O.S. (Nitric Oxide, Nitrogen)    UN1956

Topical, Rx Only NOT FOR INHALATION BEYOND THE NASOPHARYNX

Label No:  NDC  67200-004-01

Airgas Product Code: XO2NI99EA22C498

CareFusion Code: 79072

Cylinder Contents: 550 liters @ 70F     5000ppm (0.5% v/v) Nitric Oxide Balanced in Nitrogen USP/NF Please see Certificate of Analysis for assay result if exact value is needed

CAS Numbers: 10102-43-9 NO      7727-37-9   N2

Read and understand Material Safety Data Sheet before use. Indications and Directions: Use only in accordance with Institutional Review Board approved protocol.

WARNING: Administration of this gas mixture 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, testing methods, and with the hazards, contraindications, and side effects and precautions to be taken.

CAUTION: High pressure gas. Can cause rapid suffocation without warning. Use equipment rated for cylinder pressure. Store and use with adequate ventilation. Secure cylinder in use and storage. Close valve after each use and when empty. Cylinder temperature should not exceed 125F (52C).

FIRST AID: If inhaled, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medical help.

Return with 150 psig. To be refilled only by a pharmaceutical facility authorized by CareFusion.

Manufactured for: CareFusion 207, Inc. 22745 Savi Ranch Parkway Yorba Linda, CA 92887-4668 USA For product inquiry: 1-314-283-1830

Manufactured by: Airgas Specialty Gases 12722 South Wentworth Avenue Chicago, IL 60628

Do Not Remove This Label.                                     80889-04  (01/10)

Nitric Oxide Nitrogen Mix  Nitric Oxide Nitrogen Mix  gas

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 67989-011 Route of Administration RESPIRATORY (INHALATION) DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Nitric Oxide (Nitric Oxide) Nitric Oxide 5 mL  in 1 L Nitrogen (Nitrogen) Nitrogen 955 mL  in 1 L

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 67989-011-01 550 L In 1 CYLINDER None 2 67989-011-02 209.6 L In 1 CYLINDER None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved medical gas		05/01/2010

Labeler - Airgas Specialty Gases (097167860)

Establishment
Name	Address	ID/FEI	Operations
Airgas Specialty Gases		097167860	manufacture

Revised: 03/2011Airgas Specialty Gases