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Hemanext Partners with Sickle Cell 101 to Sponsor Sickle Cell Education

Hemanext, News, SCD

Sickle Cell Disease (SCD) Affects Over 20M Worldwide, including 100K Americans1,2 LEXINGTON, MA and SAN FRANCISCO, CA – Jul 28, 2021 – Hemanext Inc. a privately held, US-based medical technology company dedicated to improving the quality, safety, efficacy, and cost of...

Recent Posts

  • Hemanext Inc. Announces a Significant Milestone with FDA Marketing Authorization for Hemanext ONE®, Hemanext’s Innovative Red Blood Cell (RBC) Processing and Storage System
  • Hemanext Announces Founder Martin Cannon’s Retirement, Appoints Andrew Dunham as CEO, and Raises Funding for Growth
  • Hemanext Announces Membership in European Confederation of Pharmaceutical Entrepreneurs (EUCOPE)
  • Hemanext Announces a Strategic Partnership and Investment from Vitalant
  • Hemanext Continues European Rollout of Hemanext ONE® RBC Processing and Storage System
This website may contain information on products or uses of those products that are not authorized in all countries or regions. Hemanext ONE has been granted marketing authori zation for commercial distribution via the De Novo process by the U.S. Food & Drug Administration. In Europe Hemanext ONE is CE marked which allows the medical device to be placed in the market in the EEA. Illustrations are artist's representations only and should not be considered as engineering drawings or photographs.

European Economic Area (EEA):

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 i n 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.

United States (US):

CAUTION: Hemanext ONE has been granted marketing authorization for commercial distribution via the De Novo process by the U.S. Food & Drug Administration. It is intended to pr ocess and store CP2D/AS-3 Red Blood Cells, Leukocytes Reduced (LR RBC) that have been prepared within the standard 8-hour hold time. Processing of Red Blood Cells with the HEMANEXT ONE system must be initiated within 8 hours of collection and completed within 12 hours of collection. The Red Blood Cells must be processed at room temperature (20-26°C). The HEMANEXT ONE system limits 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 RBC.

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