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TRACOE® mini REF 888-350-3.0-C

by Tracoe medical GmbH

Listed FDA GUDID listing, not in commercial distribution

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 Number04035324028696 UDI-DI Date22 Oct 2018ListedStatusListed GUDID: not in commercial distribution

Recalls

1 recall · FDA

    • Terminated Z-1667-2013 FDA Class I initiated 17 Apr 2013

    The pediatric tracheostomy tubes were mislabeled as the smaller infant tracheostomy tubes.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
TRACOE® mini
Generic Name
Tracheostomy tube, non-reinforced, non-customized, single-use
Model / Reference
REF 888-350-3.0-C
Primary DI / UDI-DI
04035324028696
510(k) Number
FDA Product Code
BTO
GMDN Term
Tracheostomy tube, non-reinforced, non-customized, single-use
Device Class
Class II
Regulation Number
868.5800
GUDID distribution status
Not in Commercial Distribution
Size
Lumen/Inner Diameter — 3.0 Millimeter

Related devices

Cleared under the same submission (K893866)

Show all (12)

Other devices from Tracoe medical GmbH

See all devices from Tracoe medical GmbH →

Properties

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

Other properties (9)

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