Provox Life Day & Night Experience Oval
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Provox Life Day & Night Experience Oval EUDAMEDFDA UDI
- Generic Name
- Tracheostoma protective filter FDA UDI
- Device Name
- Provox Life Day & Night Experience EUDAMEDProvox 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
- 8061 EUDAMEDFDA 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
- 8061 FDA UDI
- Primary DI / UDI-DI
- 07331791015618 EUDAMEDFDA UDI
- Basic UDI-DI
- 7331791-KIT-0-000-0005-J3 EUDAMED
- FDA Product Code
- BYD FDA UDI
- EMDN Code
- R060299 HUMIDIFICATION SYSTEMS - OTHER EUDAMED
- GMDN Term
- Tracheostoma protective filter FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 868.5375 FDA UDI
- Market of Registration
- Denmark EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
Yes
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Tracheostoma protective filter
Provox Life Day & Night Experience Oval 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.
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- Removal Aid — ATOS MEDICAL INC. · Class I
- Provox Life Home HME — ATOS MEDICAL INC. · Class I
- Provox Life Night HME — ATOS MEDICAL INC. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
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 |
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Manufacturer
- Manufacturer
- Atos Medical Inc.
Sources (2)
- FDA UDI a1c7144d-dd12-43e3-a800-17ddfa88b243 36 fields · synced Jul 13, 2026
- EUDAMED 2d7dc2e2-5c8d-4c97-9b8f-c4d2babffbc1 61 fields · synced Jul 13, 2026