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Importer Manufacturer Name: Name: Bionostics, Inc. Address: Address: 7 Jackson Road Devens, Massachusetts USA 01434 Telephone: Telephone: +01 978 772 7070 Fax: Fax: +01 978 772 7072 Product Name: Glucose Control Solution for Abbott Diabetes Care FreeStyle® Catalog No: PRT 01013, PRT 01077, PRT 00318 Product Use: buffered aqueous solution for in vitro use for quality control of glucose monitors Labeling Text N/A Danger Symbol(s) N/A Shipping Name N/A IATA Not known Material Safety Data Sheet Page 1 of 2 QMS-MSDS-AbbottDiabetesCare ECO No. 3745, Rev. A, Issue Date: 09/24/04 Section I Chemical Product and Company Identification Section II Composition / Information on Ingredients Chemical Family: salt water solution with dye Chemical Name: N/A Component CAS Number Concentration Ranges EEE Symbol / Risk Phrases Contains no hazardous ingredients with concentration greater than 1% or carcinogens with concentration greater than 0.1% Section III Hazards Identification Eye Contact May cause irritation if in contact with eye. Skin Contact Skin contact may cause irritation. Ingestion Though not a likely route of occupational exposure, ingestion of this product may cause choking, vomiting or nausea. Inhalation N/A Chronic Exposure N/A Section IV First Aid Measures Eye Contact Although no adverse health reactions are expected from the normal use of this product, it is recommended flush eyes with water and seek medical advice whenever there has been a potential injury to the eye. Skin Contact If contact with this product leads to redness, inflammation, or irritation, flush the exposed area with running water. If irritation persists, get medical attention. Ingestion As a precaution, get medical attention if there has been ingestion of this product. Inhalation If breathing becomes difficult, remove victim to fresh air. Get medical attention Chronic Exposure N/A Section V Firefighting Measures Autoflammability not determined Flash Point (test method) not determined Extinguishing Media Use fire extinguishing media appropriate for site conditions. Special Firefighting Procedures Structural fire fighting gear and self-contained breathing apparatus will provide adequate protection if this product is in a fire area. Fire and Explosion Hazards not determined Hazardous Combustion Products Thermal decomposition may emit carbon monoxide and carbon dioxide. Upper Explosion Limit (%) not determined Lower Explosion Limit (%) not determined Section VI Accidental Release Measures Spill and Leak Procedures Use an absorbent material to contain/pick up the spilled solution. Section VII Handling and Storage Storage Temperature Store vials as directed in the package insert. Handling / Storage Handle and store vials as directed in the package insert. Ventilation Requirements No special requirements Sensitivity to Static Electricity not known Sensitivity to Mechanical Impact not known BIONOSTICS is a trademark of Bionostics, Inc., Devens, MA Abbott Diabetes Care and FreeStyle are registered trademarks of Abbott Diabetes Care, Almeda, CA © 2004 Bionostics, Inc. Abbott Diabetes Care FreeStyle Control Page 2 of 2 QMS-MSDS-AbbottDiabetesCare ECO No. 3745, Rev. A, Issue Date: 09/24/04 Section VIII Exposure Controls / Personal Protection Respiratory Protection Respiratory protection is not required under normal use of this product. Ventilation Supplemental ventilation is not required for the normal use of this product. Protective gloves Gloves are not required for normal use of this product. Other Protective Equipment None required Other Engineering controls Eye wash stations and deluge showers. Work Practices Do not place in mouth. Hygienic Practices Do not eat, drink, or smoke while working with this product. Section IX Physical and Chemical Properties Pure substance or preparation Preparation Physical Form Liquid Appearance / Odor Red, odorless pH as is neutral Odor threshold Not determined Boiling point (760 mmHg) not determined Melting / Freezing point Not determined Solubility in Water complete Partition coefficient Not determined Relative density not determined Evaporation rate Not determined Vapor pressure (mmHg) not determined Vapor density (air = 1) Not determined Viscosity not determined Volatiles Not determined Volatile Organic Compounds not determined Autoflammability Not determined Flash point not determined Oxidizing properties Not determined Section IX Physical and Chemical Properties Stability Stabile Materials to avoid Strong bases, strong acids and water reactive materials Hazardous decomposition products Thermal decomposition may emit carbon monoxide and carbon dioxide. Section XI Toxicological Information Route of Entry Ingestion, skin and/or eye contact. Effects of chronic exposure not known Effects of acute exposure not known Special health effects not known Target organs not known Cancer Lists NTC Carcinogen Ingredient CAS Nr. Known Anticipated IARC Category Section XII Ecological Information Potential effect on environment Not known Potential to bioaccumulate not known Mobility Not known Ecotoxicity not known Persistence and degradeability Not known Aqua toxicity not known Section XIII Disposal Considerations Waste disposal Please consult local, state and federal regulations for additional guidance on disposal. Empty container warnings not known Section XIV Transport Information (See also Section IX) ADR / RID not known CEFIC Tremcard number not known Hazchem code not known Kemmler code not known IMDG classification not known IATA classification not known Marine Pollutant not known UN number (S.I.N) not known UN class not known UN packing group not known Section XV Regulatory Information EEC hazard classification not known Risk phrases not known Safety phrases not known Section XVI Other Information Directives 88/379/EEC and 91/155/EEC have been considered when compiling this SDS; the information is provided for health and safety assessment by an industrial user. Reference should be made to any relevant local or national health, safety or environmental legislation. This information does not constitute indication of suitability for specific uses. The information, data and recommendations contained herein are based upon information believed by Bionostics, after reasonable investigation and research, to be accurate; however, Bionostics does not warrant the accuracy of this information. All materials and mixtures may present unknown hazards and should be used with caution. When necessary or appropriate, independent opinions regarding the risk of handling or exposure should be obtained from trained professionals. Bionostics disclaims any warranty against patent infringement and the implied warranties of merchantability and fitness for a particular purpose. Customer's sole and exclusive remedy shall be replacement of the product or return of the product and refund of the purchase price, at Bionostics' option. In no case shall Bionostics be liable for incidental or consequential damages, including lost profits.