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TRACOE vario

FDA UDI

Class II (US FDA UDI)

by Tracoe medical GmbH

Identity

Trade Name
TRACOE vario FDA UDI
Generic Name
Tracheostomy tube, reinforced, non-customized, single-use FDA UDI
Device Name
TRACOE vario Tracheostomy Tube Spiral-Reinforced, with Adjustable Neck Flange FDA UDI
Model / Reference
REF 455-06 FDA UDI
Description
TRACOE vario Tracheostomy Tube Spiral-Reinforced, with Adjustable Neck Flange FDA UDI

Identifiers

Catalog Number
REF 455-06 FDA UDI
Primary DI / UDI-DI
04035324012343 FDA UDI
510(k) Number
K203362 FDA UDI
FDA Product Code
JOH FDA UDI
GMDN Term
Tracheostomy tube, reinforced, non-customized, single-use 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

Yes

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
MRI Safety
MR Unsafe FDA UDI

Dimensions & Sizes

Size
Lumen/Inner Diameter — 6.0 Millimeter FDA UDI

Category: Tracheostomy tube, reinforced, non-customized, single-use

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

Similar devices

Also classified as Tracheostomy tube, reinforced, non-customized, single-use.

Cleared under the same submission

K203362 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 6e921395-395c-4b57-90ad-b511f3a1f5ae 38 fields · synced May 30, 2026