Prismaflex System

  • Model / Serial
    All Lots and Serial Numbers
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: United States (including Puerto Rico), and countries of: Canada, Australia, New Zealand, China, Bangladesh, Japan, Malaysia, Myanmar, Sri Lanka, India, Singapore, Vietnam, Hong Kong, Korea, Taiwan, Indonesia, Bruni, Philippines, Thailand, Argentina, Chile, Costa Rica, Dominican Republic, Haiti, Barbados, Bermuda, Venezuela, Cuba, Mexico, Colombia, Brazil and EMEA.
  • Product Description
    Prismaflex System, Product Code 107493 || Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. " Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or more with diseases where removal of plasma components is indicated. " Continuous Renal Replacement Therapy (CRRT) in conjunction with the MARS system to conduct MARS treatments for patients weighing 20 kilograms or more. All treatments administered via the Prismaflex control unit must be prescribed by a physician.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Baxter Healthcare Corporation, 1 Baxter Pkwy, Deerfield IL 60015-4625
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

13 devices with a similar name

Learn more about the data here

  • Model / Serial
    Product Codes: 107493, 113082, 113874, 114489 and 114870. Serial Numbers: All
  • Product Description
    Continuous Renal Replacement Therapy (CRRT)
  • Manufacturer
  • Model / Serial
    Software 5.00 or 6.00 with "Citrate - Calcium via prismaflexe Syringe Pump" anticoagulation method unlocked.
  • Product Description
    Dialysis system
  • Manufacturer
  • Model / Serial
  • Product Description
    Injections / Infusions / Transfusions / Dialysis
  • Manufacturer
  • Model / Serial
    Model Number: 107493, 114489, 114870, 955052 Serial Number: all
  • Product Description
    Electromechanical medical devices
  • Manufacturer
  • Model / Serial
    Model Number: 107493 113082 113874 114489 114870 955052
  • Product Description
    Electromechanical medical devices
  • Manufacturer
8 more