SIGMASpectrum

  • 모델명 / 제조번호(시리얼번호)
    All versions
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (nationwide) including Puerto Rico, and Canada.
  • 제품 설명
    SIGMASpectrum Infusion Pump Master Drug Library (MDL) Editor software. || Product Usage: || A customized in-house library of all IV and epidural drugs, along with their safe delivery parameters.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Sigma, 711 Park Ave, Medina NY 14103-1036
  • Source
    USFDA

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

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Contact CDRH for list of affected serial numbers (5976 units)
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution, Puerto Rico and Canada
  • 제품 설명
    sigma spectrum VOLUMETRIC INFUSION PUMP with Master Drug Library, V6 Spectrum Infusion Pump, Product Code 35700BAX and 35700BAXR, Unique Device Identifier GTIN 00085412091570, Rx ONLY -- Sigma, LLC Medina, NY 14103 --- NOTE: The speakers are a part of the rear case assembly located in the back of the infusion pump. The speaker is intended to generate audible tones during each keystroke, and during alarm conditions. However, some speakers have a variation in their internal wiring that increases the potential for the speaker to fail prematurely. Spectrum Infusion Pumps with non-functional speakers will continue to display visual alarm indications, and will otherwise continue to operate as intended.
  • Manufacturer