TRACOE mini REF 355-6.0-C54

by Tracoe medical GmbH

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

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

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number04035324016273 UDI-DI	Date18 Oct 2015Listed	StatusListed GUDID: 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

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Withdrawn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 / Ref / Catalog: REF 355-6.0-C54

Primary DI / UDI-DI: 04035324016273
510(k) Number: K893866
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: In Commercial Distribution

Size: Lumen/Inner Diameter — 6.0 Millimeter

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Properties

Sterile
Prescription Use
Lot / Batch Number
Expiration Date

Other properties (10)

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
Manufacturing Date: No