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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 and Low Pressure Cuff FDA UDI
Model / Reference
REF 450-06 FDA UDI
Description
TRACOE vario Tracheostomy Tube Spiral-Reinforced, with Adjustable Neck Flange and Low Pressure Cuff FDA UDI

Identifiers

Catalog Number
REF 450-06 FDA UDI
Primary DI / UDI-DI
04035324012275 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

The Tracoe vario is a high-quality, adjustable tracheostomy tube designed for patients with unusual neck masses or those requiring an artificial airway. Made from durable plastic with wire reinforcement, this device features an adjustable neck flange and low-pressure cuff, ensuring a secure and comfortable fit.

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 c2c1c1ba-adb8-4fba-ac84-c5d07276f870 38 fields · synced Jul 6, 2026