Identity
- Trade Name
- Provox Flush EUDAMEDFDA UDI
- Generic Name
- Tracheoesophageal speech valve irrigation device FDA UDI
- Device Name
- Provox Flush EUDAMEDProvox Flush is intended to be used to flush drinking water or air through the inner lumen of a Provox voice prosthesis for cleaning purposes. The Flush is intended for both home and clinical use by patient or clinician. Single patient re-use. FDA UDI
- Model / Reference
- 8109 EUDAMEDFDA UDI
- Description
- Provox Flush is intended to be used to flush drinking water or air through the inner lumen of a Provox voice prosthesis for cleaning purposes. The Flush is intended for both home and clinical use by patient or clinician. Single patient re-use. FDA UDI
Identifiers
- Catalog Number
- 8109 FDA UDI
- Primary DI / UDI-DI
- 07331791005930 EUDAMEDFDA UDI
- Basic UDI-DI
- 7331791-VPS-A-000-0001-RK EUDAMED
- FDA Product Code
- LRC FDA UDI
- EMDN Code
- Q0399 ENT DEVICES - OTHER EUDAMED
- GMDN Term
- Tracheoesophageal speech valve irrigation device FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 874.4420 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
Provox Flush 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-VPS-A-000-0001-RK | 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 009f02c9-2540-4d2d-b08a-5f9852f40b06 61 fields · synced Jun 18, 2026
- FDA UDI efda058a-5123-4dc4-9b9a-efdbaae802b0 36 fields · synced May 30, 2026