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Bivona SU20AN55NGG113S

by Icu Medical, Inc. United States GUDID

Product code JOH

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number15019517219456 UDI-DIDate6 Feb 2020ListedStatusIn distribution

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Listed
  • Not covered

United States — GUDID listing Listed

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.

Specification

GUDID · synced 23 Oct 2026

Trade Name
Bivona
Generic Name
Tracheostomy tube, non-reinforced, custom-made
Model / Reference
SU20AN55NGG113S
Primary DI / UDI-DI
15019517219456
510(k) Number
FDA Product Code
JOH
GMDN Term
Tracheostomy tube, non-reinforced, custom-made
Device Class
Class II
Regulation Number
868.5800
Commercial Distribution
In Commercial Distribution
MRI Safety
MR Safe

Related devices

Category: Tracheostomy tube, non-reinforced, custom-made

Cleared under the same submission (K923878)

Show all (12)

Other devices from Icu Medical, Inc.

See all devices from Icu Medical, Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date
Other properties (9)
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No

Sources (1)

  • FDA UDI 37d0315f-60d7-482a-9787-52dcc98a94b6 33 fields · synced 23 Oct 2026