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Information contained herein for distribution outside the United States only. The site may contain information on products or uses of those products that are not cleared, approved, or otherwise authorized in all countries or regions. The Hemanext ONE® System has not been cleared, approved, or otherwise authorized by the US Food & Drug Administration for commercial distribution in the United States.

CAUTION: The novel Hemanext ONE Red Blood Cell (RBC) Processing and Storage System is a prescription medical device designed to limit oxygen and carbon dioxide levels in the storage environment to be used by or under the direction of a physician. It is CE-marked as a blood container set for the processing and storage of CPD/PAGGSM Red Blood Cells, Leukocytes Reduced (LRRBC) that have been prepared and processed with the HEMANEXT ONE system within 24-hours of collection. The HEMANEXT ONE system limits the O2 and CO2 levels in the storage environment. Red Blood Cells Leukocytes Reduced, O2/CO2 Reduced may be stored for up to 42 days at 1-6°C. HEMANEXT ONE is used for volumes no greater than 350 ml of LR. Prior to use, for more detailed information reference the Instructions for Use regarding the Device Description, Indications, Contraindications, Warnings, Precautions, and Adverse Events.

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