Identity
- Trade Name
- COMFIT™ EUDAMEDCOMFIT FDA UDI
- Generic Name
- Endotracheal tube holder FDA UDI
- Device Name
- COMFIT™ EUDAMEDCOMFIT Endotracheal Tube Holder FDA UDI
- Model / Reference
- 42-1820 EUDAMEDFDA UDI
- Description
- COMFIT Endotracheal Tube Holder FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00888937016642 EUDAMEDFDA UDI
- Basic UDI-DI
- 0888937TD009ZM EUDAMED
- FDA Product Code
- JAY FDA UDI
- EMDN Code
- R01038099 ENDOTRACHEAL TUBES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED
- GMDN Term
- Endotracheal tube holder FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 868.5280 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
Comfit™ 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 |
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Manufacturer
- Manufacturer
- CooperSurgical, Inc.
- EUDAMED SRN
- US-MF-000002607
- Authorised Representative
- CooperSurgical Distribution B.V. NL-AR-000000059
Sources (2)
- EUDAMED ed9e0b65-9091-4a98-9875-6fc40849ffa2 61 fields · synced Jul 10, 2026
- FDA UDI 0959b035-2d05-4196-a148-8228eda7287f 33 fields · synced May 29, 2026