FDA-Device2018-06-13Class II
Bivona¿ Tracheostomy Tube Tracheostomy Tubes
Smiths Medical ASD Inc.
Hazard
Carton labeling is printed with "Sterile" indicated labeling, however the device is not sold as sterile.
Sold states
Domestic distribution to CA, FL, GA, ID, NJ, NM, OH, VA. International distribution to France.
Affected count
16 units
Manufactured in
6000 Nathan Ln N, N/A, Minneapolis, MN, United States
Products
Bivona¿ Tracheostomy Tube Tracheostomy Tubes
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2114-2018Don't want to check this manually?
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