Identity
- Trade Name
- Provox Life Day & Night Experience Plus FDA UDI
- Generic Name
- Tracheostoma protective filter FDA UDI
- Device Name
- Provox Life HMEs are single use heat and moisture exchangers for patients breathing through a tracheostoma Provox Life Adhesives are single use adhesives that provide attachment for Provox Life HMEs and accessories after total laryngectomy FDA UDI
- Model / Reference
- 8062 FDA UDI
- Description
- Provox Life HMEs are single use heat and moisture exchangers for patients breathing through a tracheostoma Provox Life Adhesives are single use adhesives that provide attachment for Provox Life HMEs and accessories after total laryngectomy FDA UDI
Identifiers
- Catalog Number
- 8062 FDA UDI
- Primary DI / UDI-DI
- 07331791015625 FDA UDI
- FDA Product Code
- BYD FDA UDI
- GMDN Term
- Tracheostoma protective filter FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5375 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
Yes
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
Category: Tracheostoma protective filter
Provox Life Day & Night Experience Plus by Atos Medical Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Tracheostoma protective filter.
- Provox Life LP Kit 12 - LT 12/36, 12/55 — ATOS MEDICAL INC. · Class II
- Provox Life LP Kit 16 - LT 10/55-2HSTP — ATOS MEDICAL INC. · Class II
- Provox Life Day & Night Experience Oval — ATOS MEDICAL INC. · Class I
- Provox Life LP Kit 1 - LT 8/36, 8/55 — ATOS MEDICAL INC. · Class II
- Freevent XtraCare Mini White (30 pcs) — ATOS MEDICAL INC. · Class I
- Freevent XtraCare Mini Blue (30 pcs) — ATOS MEDICAL INC. · Class I
- Removal Aid — ATOS MEDICAL INC. · Class I
- Provox Life Home HME — ATOS MEDICAL INC. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Atos Medical Inc.
Sources (2)
- FDA UDI 3a2c753b-d399-49cc-9125-f26680d15472 36 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 18, 2026