Identity
- Trade Name
- Provox TubeBrush 12 mm EUDAMEDFDA UDI
- Generic Name
- Airway device cleaning utensil, noninvasive, reusable FDA UDI
- Device Name
- Provox TubeBrush EUDAMEDThe Provox TubeBrush is used for cleaning of the Provox LaryTube and Provox LaryButton ex situ. FDA UDI
- Model / Reference
- 7661 EUDAMEDFDA UDI
- Description
- The Provox TubeBrush is used for cleaning of the Provox LaryTube and Provox LaryButton ex situ. FDA UDI
Identifiers
- Catalog Number
- 7661 FDA UDI
- Primary DI / UDI-DI
- 07331791002663 EUDAMEDFDA UDI
- Basic UDI-DI
- 7331791-GEN-A-000-0001-E9 EUDAMED
- Unit of Use DI
- 07331791016509 EUDAMED
- FDA Product Code
- EPE FDA UDI
- EMDN Code
- R01058099 TRACHEOSTOMY AND LARYNGECTOMY CANNULAS - VARIOUS ACCESSORIES EUDAMED
- GMDN Term
- Airway device cleaning utensil, noninvasive, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 868.5795 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 12 Millimeter FDA UDI
Provox TubeBrush 12 mm by Atos Medical AB — 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 | 7331791-GEN-A-000-0001-E9 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Atos Medical AB
- EUDAMED SRN
- SE-MF-000000725
Sources (2)
- EUDAMED 5666dd81-9417-4218-bd16-8fc99841bfad 61 fields · synced Aug 4, 2026
- FDA UDI b8611978-97a7-4585-bb7a-93aa1a3c99e0 37 fields · synced May 30, 2026