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Bivona FU13IN45NSA039S

by ICU Medical, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

1 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10351688752932 UDI-DI Date28 Aug 2015ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · FDA

    • Terminated Z-0260-2007 FDA Unclassified (pre-2012) initiated 17 Nov 2006

    Mislabeled as to size: The product is 47.5 mm in length, but the label lists the length as 4.75 mm.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Bivona
Generic Name
Tracheostomy tube, non-reinforced, non-customized, reusable
Model / Reference
FU13IN45NSA039S
Primary DI / UDI-DI
10351688752932
510(k) Number
FDA Product Code
JOH
GMDN Term
Tracheostomy tube, non-reinforced, non-customized, reusable
Device Class
Class II
Regulation Number
868.5800
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional

Related devices

Category: Tracheostomy tube, non-reinforced, non-customized, reusable

Cleared under the same submission (K923878)

Show all (12)

Other devices from ICU Medical, Inc.

See all devices from ICU Medical, Inc. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (8)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No