Carefusion 211 Inc

2 devices in the database

  • Model / Serial
    Catalog Code 17310, 17311, 17312 (each of the affected devices is individually seralized)
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Cyprus, Estonia, Brazil, Kuwait, United Arab Emirates, Slovenia, Lithuania, Latvia, Belgium, Bermuda, Ecuador, Guatemala, Italy, Canada, Australia, Netherlands, Germany, United Kingdom, Spain, Czech (Rep), Nicaragua, China, Bangladesh, Morocco, Bolivia, Vietnam, Slovakia, Paraguay, Argentina, Turkey, Chile, Singapore, Japan, Colombia, Egypt, Hong Kong, Honduras, India, Croatia, Venezuela, Saudi Arabia, Greece, Hungary, Mexico, Austria, Ireland,Indonesia, Dominican Republic, Portugal, South Africa, Panama, Philippines, Libyan Jamahiriya, Jordan, Malaysia, France, Thailand, Peru, Costa Rica, Korea, and Taiwan.
  • Product Description
    AVEA Ventilator (Catalog Code 17310, 17311, 17312). || The AVEA is intended to provide continuous respiratory support in an institutional health care environment (e.g. hospitals). It may be used on neonatal through adult patients. It should only be operated by properly trained clinical personnel, under the direction of a physician. Prescription Use: Federal law restricts the sale of this device except by or on order of a physician.
  • Model / Serial
    identified by with serial number logic of TXXXXX or SXXXXX.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    AirLife Nebulizer Heater, Catalog Code 2M8021 || The AirLife Nebulizer Heater is part of the heated nebulizer system intended to provide warm bland aerosol therapy to respiratory patients. The system is used in conjunction with a standard oxygen flowmeter, which by providing pressurized oxygen powers the nebulizer creating ultra-fine particles in the therapeutic aerosol. The heater warms the solution before it reaches the aerosol jet in the nebulizer and heats the dilution air before it is entrained into the aerosol stream. An aluminum heat exchanger on the nebulizer cap transfers the thermal energy to a nebulizer solution bottle warming the solution prior to aerosolizing.

2 manufacturers with a similar name

Learn more about the data here

  • Manufacturer Address
    Carefusion 211 Inc dba Carefusion, 22745 Savi Ranch Pkwy, Yorba Linda CA 92887-4668
  • Source
    USFDA