Prismaflex System

  • 모델명 / 제조번호(시리얼번호)
    All Lots and Serial Numbers
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    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

제조사

  • 제조사 주소
    Baxter Healthcare Corporation, 1 Baxter Pkwy, Deerfield IL 60015-4625
  • 제조사 모회사 (2017)
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 13 건

데이터에 대해 더 자세히 알아보기 여기

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