Identity
- Trade Name
- Dale 280 Breezlock ET Tube Holder EUDAMEDDale Endotracheal Tube Holder FDA UDI
- Generic Name
- Endotracheal tube holder FDA UDI
- Device Name
- Endotracheal Tube Holder EUDAMEDDale Endotracheal Tube Holder, Fits ET Tube sizes 7.0mm - 10.0mm FDA UDI
- Model / Reference
- 280 EUDAMEDFDA UDI
- Description
- Dale Endotracheal Tube Holder, Fits ET Tube sizes 7.0mm - 10.0mm FDA UDI
Identifiers
- Catalog Number
- 280 FDA UDI
- Primary DI / UDI-DI
- 00817612020889 EUDAMEDFDA UDI
- Basic UDI-DI
- 0817612022806F EUDAMED
- FDA Product Code
- CBH 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
- 868.5770 FDA UDI
- Market of Registration
- Germany 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
No
FDA UDI
Over-the-Counter
Yes
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
No
FDA UDI
Dale 280 Breezlock ET Tube Holder by Dale Medical Products, 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 | 0817612022806F | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Dale Medical Products, Inc.
- EUDAMED SRN
- US-MF-000019061
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 05804f5d-c7a4-4483-8477-2622ee29b288 61 fields · synced Oct 7, 2026
- FDA UDI 39e63938-c04a-4fdf-a8fa-c003d6a8c9fc 35 fields · synced May 30, 2026