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Hemanext® Inc. Receives CE Mark Certification for Innovative Red Blood Cell (RBC) Processing & Storage System

News, Red Blood Cell

Hemanext® Inc. Receives CE Mark Certification for Innovative Red Blood Cell (RBC) Processing & Storage System Company to launch Hemanext ONE® RBC Processing and Storage System in select European markets in 2021, with wider distribution in Europe and the Americas...
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Recent Posts

  • European Patients Have Begun Receiving Transfusions with Hemanext ONE® RBC Processing and Storage System
  • Hemanext Launches European Sales of Hemanext One® System in Italy and The Nordics
  • Hemanext Announces Publication of Hypoxic Blood Storage Study in Blood Advances
  • Hemanext to Begin Rollout of Hemanext ONE® RBC Processing and Storage System in Europe
  • Hemanext Announces Appointment of Daan Kok as the Executive Vice President & General Manager of Hemanext for Europe, Middle East, and Africa
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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© 2021 Hemanext, Inc. All Rights Reserved. This website and the information contained herein is for informational purposes and only for selected audiences, like healthcare professionals. It is not directed to patients.

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