Respironics BiPAP Focus Noninvasive Ventilator System

  • Model / Serial
    Model Numbers: 8-400169-00, 7-400076-00, 8-400179-00, 8-400258-00, 8-400259-00, 8-400260-00, 8-400261-00 and 8-400216-00.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide to Argentina, Australia, Belgium, Brazil, Cambodia, Canada, Colombia, Denmark, Ecuador, Egypt, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Libya, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Portugal, Puerto Rico, Russian Fed., Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom, United States and Venezuela.
  • Product Description
    Respironics BiPAP Focus Noninvasive Ventilator System. || The BiPAP Focus is a non-invasive, pressure support ventilator used to augment the breathing of patients suffering from acute or chronic respiratory insufficiency, respiratory failure or to maintain airway patency and provide respiratory support to patients who experience obstructive sleep apnea. Nasal and full face masks are used with this device. The BiPAP Focus is intended for use in acute, sub-acute and intra-hospital transport settings.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Respironics California Inc, 2271 Cosmos Ct, Carlsbad CA 92011-1517
  • Manufacturer Parent Company (2017)
  • Source
    USFDA