Device Recall pO2 D999 membrane units

  • Modèle / numéro de série
    Part #: 942-042, Lot #: R0971
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) including states of: CO, CT, GA, MA, MO & MS and country of: Canada.
  • Description du dispositif
    pO2 D999 membrane units. Distributed by Radiometer America, Inc., Westlake, OH 44145 || pO2 membrane units, ordering number 942-042 Intended use is in vitro testing of samples of whole blood for pO2 (partial pressure of oxygen).
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Radiometer America Inc, 810 Sharon Dr, Westlake OH 44145-1521
  • Société-mère du fabricant (2017)
  • Source
    USFDA