Identity
- Trade Name
- TRACOE twist FDA UDI
- Generic Name
- Tracheostomy tube, non-reinforced, non-customized, single-use FDA UDI
- Device Name
- Tracheostomy Tube, Fenestrated, with Low Pressure Cuff FDA UDI
- Model / Reference
- REF 302-06 FDA UDI
- Description
- Tracheostomy Tube, Fenestrated, with Low Pressure Cuff FDA UDI
Identifiers
- Catalog Number
- REF 302-06 FDA UDI
- Primary DI / UDI-DI
- 04035324033515 FDA UDI
- 510(k) Number
- K961449 FDA UDI
- FDA Product Code
- JOH 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
- 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
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 6.0 Millimeter FDA UDI
Category: Tracheostomy tube, non-reinforced, non-customized, single-use
TRACOE twist by Tracoe medical GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Tracheostomy tube, non-reinforced, non-customized, single-use.
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Cleared under the same submission
K961449 also covers:
- TRACOE modular — Tracoe medical GmbH
- TRACOE twist — Tracoe medical GmbH
- TRACOE twist — Tracoe medical GmbH
- TRACOE twist — Tracoe medical GmbH
- TRACOE twist — Tracoe medical GmbH
- TRACOE twist — Tracoe medical GmbH
- TRACOE twist — Tracoe medical GmbH
- TRACOE twist — Tracoe medical GmbH
- TRACOE twist — Tracoe medical GmbH
- TRACOE twist — Tracoe medical GmbH
- TRACOE twist — Tracoe medical GmbH
- TRACOE twist — Tracoe medical GmbH
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Tracoe medical GmbH
Sources (1)
- FDA UDI b2916f51-e913-4bac-b218-cb78ec59339c 38 fields · synced Jun 1, 2026