SIGMASpectrum

  • Modèle / numéro de série
    All versions
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) including Puerto Rico, and Canada.
  • Description du dispositif
    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

Fabricant

  • Adresse du fabricant
    Sigma, 711 Park Ave, Medina NY 14103-1036
  • Source
    USFDA

Un dispositif médical avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    Contact CDRH for list of affected serial numbers (5976 units)
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution, Puerto Rico and Canada
  • Description du dispositif
    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