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TRACOE comfort

FDA UDI

Class II (US FDA UDI)

by Tracoe medical GmbH

Identity

Trade Name
TRACOE comfort FDA UDI
Generic Name
Tracheostomy tube, non-reinforced, non-customized, reusable FDA UDI
Device Name
Tube with Inner Cannulas FDA UDI
Model / Reference
REF 102-12D FDA UDI
Description
Tube with Inner Cannulas FDA UDI

Identifiers

Catalog Number
REF 102-12D FDA UDI
Primary DI / UDI-DI
04035324005017 FDA UDI
510(k) Number
K781729 FDA UDI
FDA Product Code
BTO FDA UDI
GMDN Term
Tracheostomy tube, non-reinforced, non-customized, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Lumen/Inner Diameter — 10.8 Millimeter FDA UDI

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

TRACOE comfort by Tracoe medical GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Tracheostomy tube, non-reinforced, non-customized, reusable.

Cleared under the same submission

K781729 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Tracoe medical GmbH

Sources (1)

  • FDA UDI 5aa346e1-1ad1-473d-baff-ec0768c31ebc 38 fields · synced May 30, 2026