FDA Grants 510(k) Clearance to B. Braun for Infusomat Space Pump
The FDA has granted infusion therapy and pain management devicemaker B. Braun Medical 510(k) clearance for its second-generation, large-volume Infusomat space pump.
The pump delivers parenteral fluids, medications, blood and blood products through intravenous, intra-arterial, subcutaneous and epidural routes of administration.
The company says one of the device’s unique features allows healthcare workers to change care units without having to stop or reprogram the infusion, which helps maintain drug library compliance.
Additionally, the pump features real-time wireless reporting and EMR integration with the company’s management software. — Michael Cipriano