High Frequency Ventilator

  • Modèle / numéro de série
    Serial numbers 2585 and below.
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide, Military medical center, Canada, and Czech Republic
  • Description du dispositif
    Life Pulse High Frequency Ventilator (HFV)
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Bunnell, Inc., 436 Lawndale Dr, Salt Lake City UT 84115-2917
  • Source
    USFDA

5 dispositifs médicaux avec un nom similaire

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  • Modèle / numéro de série
    Patient Circuit (catalog # 902) lot # on each individual patient circuit label: 12C092, 12C102, 12C115, 12C125, 12C136, 12D159, 12D172, 12D189, 12E204, 12E211, 12E224, 12F241, 12F254, 12F271, 12G279, 12G290, 12G307, 12G321, 12H330, 12H349, 12I362, 12I371, 12I397, 12J413, 12J430, 12J448, 12K457, 12K471 Patient Circuit Kit (catalog # 397) lot # on the label on outside of box: 12C099, 12C114, 12C124, 12C135, 12D152, 12D170, 12D188, 12E203, 12E210, 12E223, 12F238, 12F255, 12F274, 12G209, 12G280, 12H334, 12H341, 12I356, 12I369, 12I392, 12J411, 12J425, 12J447, 12K467, 12K479
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Canada, Australia, Malaysia, and Uruguay (animal study only).
  • Description du dispositif
    Patient Circuit used with the Life Pulse High Frequency Ventilator. The Patient Circuit is a required disposable component of the Life Pulse High Frequency Ventilator. || Model #(s): || Individual Patient Circuit - catalog # 902 || Patient Circuit Kit - catalog # 937: contains 2 circuits and 2 x 2.5 & 2 x 3.5 LifePort Adapters. || Labeling states manufactured by: Bunnell Incorporated 436 Lawndale Drive, Salt Lake City, Utah 84115. || Used for ventilating critically ill infants with pulmonary interstitial emphysema and infants with respiratory distress syndrome complicated by pulmonary air leaks, who are, in the opinion of their physicians, failing on conventional ventilation. The Patient Circuit is to provide a conduit for the humidification, warming, and temperature monitoring of the pressurized gas. The Patient Circuit is indicated for seven day single use.
  • Manufacturer
  • Modèle / numéro de série
    Model 203A
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA, Australia, Canada, Czech Republic, Korea, Malaysia, Trinidad & Tobago, and Uruguay.
  • Description du dispositif
    One Cat. Life Pulse High Frequency Ventilator, Catalog Number: 203A, Manufactured by: Bunnell Incorporated Salt Lake City, Utah, Rx Only.
  • Manufacturer
  • Modèle / numéro de série
    Model 203
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA, Australia, Canada, Czech Republic, Korea, Malaysia, Trinidad & Tobago, and Uruguay.
  • Description du dispositif
    One Cat. Life Pulse High Frequency Ventilator, Catalog Number: 203, Manufactured by: Bunnell Incorporated Salt Lake City, Utah, Rx Only.
  • Manufacturer
  • Modèle / numéro de série
    Bunnell Life Pulse Patient Circuits (Used with Life Pulse High Frequency Ventilator) Manufactured after 19-12-2012 Lot Numbers: 12C092, 12E211, 12H330, 12C102, 12E224, 12H349, 12C115, 12F241, 12I362, 12C125, 12F254, 12I371, 12C136, 12F271, 12I397, 12D159, 12G279, 12J413, 12D172, 12G290, 12J430, 12D189, 12G307, 12J448, 12E204, 12G321, 12K457, 12K471ARTG number for the Ventilator: 179402
  • Classification du dispositif
  • Manufacturer