Device Recall Giraffe Incubator

  • Modèle / numéro de série
    See Attached Spreadsheat
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US (nationwide and Puerto Rico) Bahamas and Internationally to UK, Trinidad & Tobago, Taiwan, Spain, Panama, Netherlands Antilles, Mexico, Lebanon, Japan, Ireland, Honduras, El Salvador, Ecuador, Costa Rica, Colombia, Canada, Brazil, and Venezuela,
  • Description du dispositif
    Giraffe Incubator || Ohmeda Medical Giraffe Incubator-The Giraffe Incubator is an infant incubator. Incubators provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. They achieve this by providing an enclosed temperature controlled environment for the infant. This device may incorporate a Servo Controlled Oxygen Delivery System. This is indicated to provide a stable oxygen concentration within the infant compartment at the value set by the operator (21-65%).
  • Manufacturer
  • 2 Events

Fabricant

  • Adresse du fabricant
    Ohmeda Medical, 8880 Gorman Rd, Laurel MD 20723-5800
  • Société-mère du fabricant (2017)
  • Source
    USFDA