Identity
- Trade Name
- Provox FreeHands HME Moist (30 pcs) EUDAMEDFDA UDI
- Generic Name
- Tracheostoma protective filter FDA UDI
- Device Name
- Provox FreeHands HME EUDAMEDProvox ® FreeHands HME Moist / Flow are designed to allow automatic tracheostoma closure for voice prosthesis users while providing heat and moisture exchange for pulmonary rehabilitation. FDA UDI
- Model / Reference
- 8220 EUDAMEDFDA UDI
- Description
- Provox ® FreeHands HME Moist / Flow are designed to allow automatic tracheostoma closure for voice prosthesis users while providing heat and moisture exchange for pulmonary rehabilitation. FDA UDI
Identifiers
- Catalog Number
- 8220 FDA UDI
- Primary DI / UDI-DI
- 07331791008368 EUDAMEDFDA UDI
- Basic UDI-DI
- 7331791-HME-0-000-0003-XJ EUDAMED
- Unit of Use DI
- 07331791010613 EUDAMED
- 510(k) Number
- K141380 FDA UDI
- FDA Product Code
- EWL FDA UDI
- EMDN Code
- R060299 HUMIDIFICATION SYSTEMS - OTHER EUDAMED
- GMDN Term
- Tracheostoma protective filter FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 874.3730 FDA UDI
- Market of Registration
- Austria 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Provox FreeHands HME Moist (30 pcs) 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-HME-0-000-0003-XJ | 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 2fe79e6c-6106-48c9-aef2-6a356d3ebbc1 61 fields · synced Oct 6, 2026
- FDA UDI cb6193cd-9c89-4693-bb02-677f57ce8085 37 fields · synced May 30, 2026