Identity
- Trade Name
- TRAKE-FIT™ EUDAMEDTRAKE-fit FDA UDI
- Generic Name
- Tracheostomy tube neck holder, reusable FDA UDI
- Device Name
- COMFIT™ EUDAMEDTRAKE-fit Tracheostomy Tube Holder - 1 NECKBAND ; 2 WIDE HOOK/LOOP TABS FDA UDI
- Model / Reference
- 42-1820 EUDAMED43-1851 EUDAMEDFDA UDI
- Description
- TRAKE-fit Tracheostomy Tube Holder - 1 NECKBAND ; 2 WIDE HOOK/LOOP TABS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00888937016673 EUDAMEDFDA UDI
- Basic UDI-DI
- 0888937TD009ZM EUDAMED
- FDA Product Code
- CBH FDA UDI
- EMDN Code
- R01058099 TRACHEOSTOMY AND LARYNGECTOMY CANNULAS - VARIOUS ACCESSORIES EUDAMED
- GMDN Term
- Tracheostomy tube neck holder, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 868.5770 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Trake-Fit™ by CooperSurgical, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0888937TD009ZM | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- CooperSurgical, Inc.
- EUDAMED SRN
- US-MF-000002607
- Authorised Representative
- CooperSurgical Distribution B.V. NL-AR-000000059
Sources (2)
- EUDAMED 08a91d53-44f5-449c-9a88-01fe735f58e1 61 fields · synced Jun 17, 2026
- FDA UDI 18bc5665-d592-4da8-8bc5-af015a948b64 33 fields · synced May 30, 2026