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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, single-use FDA UDI
Device Name
Inner Cannula (substitute), clamp below FDA UDI
Model / Reference
REF 202-05IK-2 FDA UDI
Description
Inner Cannula (substitute), clamp below FDA UDI

Identifiers

Primary DI / UDI-DI
04035324011124 FDA UDI
510(k) Number
K781729 FDA UDI
FDA Product Code
BTO FDA UDI
GMDN Term
Tracheostomy tube, non-reinforced, non-customized, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5800 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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 — 4.0 Millimeter FDA UDI

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

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 4486c554-fc55-4f35-9e48-5eb1579038e7 38 fields · synced May 31, 2026