SAFESPEED DEVICE BLUE

SafeSpeed Device • The SafeSpeed® is a cryopreservation device which can be sealed as a closed device to hold oocytes and embryos in a specialized medium during cryopreservation procedures and subsequent long-term storage in a liquid nitrogen freezer. • The SafeSpeed ® consists on a plastic straw container optimized as a closed system for cryopreservation procedures. It is composed of an ultra fine capillary assembled on a plastic straw and a protective cover sleeve. QUALITY ASSURANCE • The SafeSpeed ® are manufactured using the highest quality materials available. Each lot is visually inspected to meet optimized dimensional specifications and to assure the integrity of each device. • The SafeSpeed ® are sterilized by gamma irradiation and validated to meet a sterility assurance level (SAL) of 10-6. • Each lot of The SafeSpeed ® is tested for: Endotoxin by European Pharmacopeia, Limulus Amebocyte Lysate (LAL) methodology. The Straw Material accomplishes with the current USP. Sterility testing is done in accordance with ANSI/AAMI/ISO 11137. All results of any specific lot are reported Certificate of Analysis (CoA) which is available upon request. STORAGE INSTRUCTIONS AND STABILITY • Store in original sterile pack at 15-30 degree Celsius. • The SafeSpeed ® is stable until the expiration date shown on package label when stored as directed. • Each SafeSpeed ® is intended for single use