Worldwide distribution: US (nationwide) including Puerto Rico and countries of: Albania, American Samoa, Argentina, Australia, Austria, Bahrain, Barbados, Bangladesh, Belgium, Bermuda, Belize, Bolivia, Bosnia and Herzegovina, Brazil, Canada, Chile,China, Colombia, Costa Rica, Croatia, Cyprus, Czech Rep, Dominican Republic, Ecuador, Egypt, Estonia, El Salvador, Finland, France, Germany, Georgia, Greece, Guatemala, Hong Kong, Honduras, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Latvia, Lebanon, Lithuania, Lybia Jamahiriya, Malaysia, Mexico, Moldova, Morocco, Netherlands, Nepal, Nicaragua, Norway, Oman, Pakistan, Palastine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Rwanda, Saudi Arabia, Singapore, Slovenia, Slovakia, Spain, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, and United Kingdom.
Description du dispositif
Product Name: AVEA¿ Ventilator. || All Models. || The affected devices are cleared under K073069 pm 1/25/2008 and K103211 on 05/06/2011. This device is a Class II medical Device. || A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.
Worldwide Distribution. US Nationwide including Guam and Puerto Rico, Canada, Albania, American Samoa, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Barbados, Belgium, Belize, Bermuda, Bolivia, Bosnia Herzegovina, Brazil, Bulgaria, Chile, China (Peoples Rep), Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvadore, Estonia, France, Georgia, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Korea (Rep), Kuwait, Latvia, Lebanon, Libyan Jamahiriya, Lithuania, Malaysia, Mexico, Moldova, Morocco, Nepal, Netherlands, Nicaragua, Norway, Occupied Palestinian Territory, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Rwanda, Saudi Arabia, Singapore, Slovakia, Slovenia, Spain, South Africa, South America, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, and Yemen.
Description du dispositif
CareFusion AVEA ventilator, all models. || Product Usage: || A continuous ventilator (respirator), intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
Worldwide Distribution - US (Nationwide) and the countries of Australia, Hungary, Paraguay, Belgium, Indonesia, Philippines, Bolivia, Ireland, Poland, Bermuda, India, Saudi Arabia, Canada, Japan, Singapore, Chile, Jordon, South Africa, China, Kuwait, Taiwan, Ecuador, Malaysia, Thailand, Egypt, Mexico, Turkey, France, Netherlands, United Kingdom, Guatemala, and Nicaragua.
Description du dispositif
AVEA GDE upgrade kit, 12284-PMN || A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
Worldwide Distribution - US (Nationwide) and the countries of Australia, Hungary, Paraguay, Belgium, Indonesia, Philippines, Bolivia, Ireland, Poland, Bermuda, India, Saudi Arabia, Canada, Japan, Singapore, Chile, Jordon, South Africa, China, Kuwait, Taiwan, Ecuador, Malaysia, Thailand, Egypt, Mexico, Turkey, France, Netherlands, United Kingdom, Guatemala, and Nicaragua.
Description du dispositif
AVEA GDE/UIM upgrade kit, 12283-PMN || A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
Worldwide Distribution - US (Nationwide) and the countries of Australia, Hungary, Paraguay, Belgium, Indonesia, Philippines, Bolivia, Ireland, Poland, Bermuda, India, Saudi Arabia, Canada, Japan, Singapore, Chile, Jordon, South Africa, China, Kuwait, Taiwan, Ecuador, Malaysia, Thailand, Egypt, Mexico, Turkey, France, Netherlands, United Kingdom, Guatemala, and Nicaragua.
Description du dispositif
Gas Delivery Engine (GDE)-refurbished, R16650A || A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.