Bivona Tracheostomy Tubes

• • Ongoing Z-0205-2024 FDA Class II ·initiated 22 Aug 2023

  The unit box is labeled with an incorrect expiration date (the manufacturing date of 3/17/2021) but the individual packaging contains the correct expiration date (3/17/2026).

• • Terminated Z-2946-2020 FDA Class II ·initiated 28 Aug 2020

  Label has the incorrect size for the tracheotomy tube.

• • Terminated Z-1465-2017 FDA Class II ·initiated 9 Feb 2017

  Smiths Medical became aware that one lot of the Bivona 3.5mm TTS Cuffed Pediatric tracheostomy tubes was incorrectly labeled for neonatal use instead of correctly labeled for pediatric use.

510(k) Number

K083641 ↗

FDA Product Code

JOH

Device Class

Class II

Regulation

21 CFR Part 868.5800

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

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