245 SERIES SWABABLE VALVES 13MM SWABABLE VIAL CAP GENERAL CHARACTERISTICS Halkey-Roberts new swabable luer valves were developed as needlefree injection ports in IV applications. They are designed to aspirate or inject fluids on demand. The valves allow multiple usage and require no cap. Valve stems will mate securely with all standard luer syringes and luer connectors. All materials are Gamma resistant, ISO 10993 compliant, DEHP-free and not made with natural rubber latex. Vial caps are available in polycarbonate. Produced under GMP: Halkey-Roberts is an ISO 90012008, ISO 13485-2003 and FDA registered manufacturing facility. The Swabable Valve series is a medical component: bulk, non-sterile, for manufacturing processing or repacking only. Customer is responsible for the Qualification/Verification ® of the HR medical component in their final device application. Luer fittings are compatible with International Standard ISO 594. PART NUMBER: PERFORMANCE CHARACTERISTICS • Priming volume: 0.06 mL Flow Rate Averages • Flow Rate @ 1 psi • Flow Rate @ 3 psi • Flow Rate @ 5 psi Swabable Stem: Blue Silicone Swabable Body: Clear Polycarbonate ETO and Gamma, based on raw material manufacturer’s data Valves are bulk packaged, double bagged in clean, closed polybags ® Shipping container is clearly labeled with HR part number, lot number and quantity POTENTIAL STERILIZATION METHOD Important: All HR® Medical Components are shipped bulk, non-sterile, and are single patient use medical device components requiring further processing (e.g. assembly, packaging, sterilization) before clinical use. The buyer is responsible for determining effects of processing/multiple usage on these components, the appropriateness of the component in the final application, and pre/post shelf life. U.S. Patents 5,360,413 and 6,089,541 and foreign patents issue