FDA-Device2019-03-13Class II
AXIUS Blower Mister Product Code/REF Number: CB-1000 The Axius Blower Mister is intended to clear an anastomotic site for improved visibility
Maquet Cardiovascular, LLC
Hazard
Potential lack of carbon dioxide (CO2) flow that may result in a procedural delay during off-pump coronary artery bypass (OPCAB).
Sold states
Worldwide distribution: US (Nationwide) and countries of: Australia, Belgium, Canada, Czech Republic, France, Germany, Korea, Netherlands, Russia, Spain, Switzerland, and United Kingdom.
Affected count
7,880 each (1,576 packs of 5)
Manufactured in
45 Barbour Pond Dr, N/A, Wayne, NJ, United States
Products
AXIUS Blower Mister Product Code/REF Number: CB-1000 The Axius Blower Mister is intended to clear an anastomotic site for improved visibility
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0983-2019Don't want to check this manually?
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