FDA-Device2013-02-27Class II
Maquet ELS Cannula 15 FR. Used for extracorporeal membrane oxygenation (ECMO) for the treatment of respiratory insufficiency in infants.
Maquet Cardiovascular Us Sales, Llc
Hazard
ELS 15 Fr Cannula could potentially contain an occluded arterial lumen.
Sold states
Worldwide Distribution-USA including the states of AZ, CO, FL, TN, and TX and the countries of Australia, Canada, Czech Republic, Dubai/Bahrain/Kuwait/Lebanon/Saudi Arabia/Yemen, France, Germany, Hong Kong, Italy, Japan, Netherlands, Singapore, South Africa, Sweden, Switzerland, Thailand, Turkey, and UK.
Affected count
41 units - US Distirbution; 216 units - OUS Distribution
Manufactured in
45 Barbour Pond Drive, N/A, Wayne, NJ, United States
Products
Maquet ELS Cannula 15 FR. Used for extracorporeal membrane oxygenation (ECMO) for the treatment of respiratory insufficiency in infants.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0839-2013Don't want to check this manually?
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