Healthcare Equipment and Supplies
Company Overview of Fenwal Inc.
Fenwal Inc. operates as a blood technology company that develops products for transfusion medicine and cell therapies worldwide. It offers component collection and processing systems, such as Alyx, a mobile and multi-component collection, processing, and leuko-filtration system; Amicus, a system that collects platelets, plasma, red cells, and mononuclear cells; Autopheresis-C, a plasma collection system that streamlines plasma collection for operators and donors; Aurora, a plasma collection system; and InterSol, a platelet additive solution that replaces plasma in a platelet component by allowing the volume of plasma transfused to be decreased. The company also provides blood collection unit...
Three Corporate Drive
Lake Zurich, IL 60047
Founded in 2006
Key Executives for Fenwal Inc.
Chief Executive Officer and President
Chief Financial Officer and Senior Vice President
Senior Vice President of Corporate Operations
Chief Executive Officer of Fresenius Kabi Region North America and President of Fresenius Kabi Region North America
President of Medical Devices for Fresenius Kabi North America
Compensation as of Fiscal Year 2013.
Fenwal Inc. Key Developments
Fenwal, Inc. Receives FDA 510(K) Clearance for the Alyx System Software Version 3.1
Nov 19 13
Fenwal Inc. announced it has received FDA 510(k) clearance for the Alyx(R) system software version 3.1. The new software gives the Alyx system a protocol for closed system plasma collection and expanded data management capabilities. The Alyx system now includes three procedures to help customers meet their collections needs: two units of red blood cells, one unit of red blood cells with plasma, and plasma alone. The Alyx system is used worldwide to collect life-saving blood components for patient transfusion. Plasma collected on the Alyx system can be processed as Fresh Frozen Plasma (FFP), Plasma Frozen within 24 hours of collection (PF24) or Plasma Frozen within 24 hours of collection held at Room Temperature for 24 hours (PF24RT24). The new Alyx system software supports remote procedure setup and paperless documentation when used with the Fenwal DXT(R) Relay data exchange software and a blood center's blood establishment computer system (BECS). With remote procedure setup, donor registration information may be entered remotely into an Alyx instrument. This helps assure data accuracy, documentation compliance, and streamlines processes. The DXT(R) Relay software also provides blood center professionals with easy-to-read, on-demand reports that consolidate procedure data from multiple Alyx systems in different locations. The reports track performance indicators and may be used to identify opportunities for operational improvement and training. The DXT(R) Relay software was built with open architecture so it is integrated seamlessly with existing blood center systems. Once integrated with a center's BECS, DXT Relay can provide data that will meet regulatory requirements for paperless documentation. Plasma is the liquid portion of blood that contains valuable proteins used to treat burn victims, bleeding disorders, human immune deficiencies and other chronic or genetic disorders. Unlike other blood components, which are stored at room temperature or refrigerated, plasma is frozen and thawed prior to fractionation or transfusion.
Fenwal Receives 60601-1 3rd Edition Certification for Aurora plasmapheresis System
Jul 25 13
Fenwal announced that it has received 60601-1 3rd edition certification for the Aurora plasmapheresis system designed for collection of plasma. 60601-1 3rd edition is the latest international consensus standard representing the current "state of the art" for medical device design and allows Fenwal to market the Aurora system in Europe. The Aurora system continues to use the company's proven and proprietary filtration separation method which enables the collection of virtually cell-free plasma and meets European requirements without further filtration. The Aurora system offers new features that improve work flow and help ensure a successful collection. Intuitive on-screen instructions simplify training for operators and provide troubleshooting assistance. An LCD display allows donors themselves to see how their donation is progressing. The Aurora system can support remote procedure set up and paperless documentation when used with the Fenwal DXT Relay software and a plasma center's donor management system. With remote procedure set up, the Aurora system can be programmed automatically based on donor registration information. These features help assure data accuracy, documentation compliance, and a more streamlined procedure. The Fenwal DXT Relay software also provides plasma center professionals with easy-to-read, on-demand reports that consolidate donor and procedure data from multiple Aurora systems at different locations. The reports track specific performance indicators and can be used to identify opportunities for operational improvement and training. The Fenwal DXT Relay software was built with open architecture so that it can seamlessly integrate with existing plasma center systems without requiring expensive, proprietary add-ons.
Fenwal Secures New FDA Clearance for Device Designed to Help Increase Plasma Available for Transfusion
Mar 19 13
Fenwal Inc. announced that it has received clearance from the U.S. Food and Drug Administration for a functionally closed disposable set used on the Fenwal Autopheresis-C(R) system to collect plasma for processing into Fresh Frozen Plasma. The Autopheresis-C system is used worldwide to collect plasma from human donors. Plasma, the liquid portion of blood, is either frozen for future transfusion, or processed by pharmaceutical companies into a range of therapies made from plasma-derived proteins. The FDA clearance announced on March 19, 2013 for a functionally closed disposable set used with the Autopheresis-C system to collect plasma that is processed into Fresh Frozen Plasma for transfusion. The closed design of the new set allows thawed plasma to be stored for up to an additional four days.
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