Identity
- Trade Name
- Thomas EUDAMEDLaerdal Thomas Tube Holder Adult (Green) FDA UDI
- Generic Name
- Endotracheal tube holder FDA UDI
- Device Name
- Thomas Tube Holder EUDAMEDThe Thomas Tube Holder secures advanced airway devices, such as Endotracheal Tubes and Supraglottic Airway devices, after insertion into the trachea or esophagus to reduce the risk of accidental extubation. FDA UDI
- Model / Reference
- Thomas Tube Holder EUDAMED600-30000 EUDAMEDFDA UDI
- Description
- The Thomas Tube Holder secures advanced airway devices, such as Endotracheal Tubes and Supraglottic Airway devices, after insertion into the trachea or esophagus to reduce the risk of accidental extubation. FDA UDI
Identifiers
- Catalog Number
- 600-30000 FDA UDI
- Primary DI / UDI-DI
- 07045430041271 EUDAMEDFDA UDI
- Basic UDI-DI
- 0704543209934SZ EUDAMED
- Direct Marketing DI
- 07045430041271 EUDAMED
- FDA Product Code
- CBH FDA UDI
- EMDN Code
- R01038001 ENDOTRACHEAL TUBE CUFFS INFLATION SYSTEMS EUDAMED
- GMDN Term
- Endotracheal tube holder FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 868.5770 FDA UDI
- Market of Registration
- Norway 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Thomas by Laerdal Medical AS — 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 | 0704543209934SZ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Laerdal Medical AS
- EUDAMED SRN
- NO-MF-000000012
Sources (2)
- EUDAMED d5297919-32a7-49fc-801e-5fa318c0d230 61 fields · synced Oct 6, 2026
- FDA UDI 8608fcc7-8a32-4021-83ad-74ee0fbc45ba 36 fields · synced May 30, 2026