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Provox Life Day & Night EXP Stability
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 8064
Identity
- Trade Name
- Provox Life Day & Night EXP Stability 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
- 8064 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
- 8064 FDA UDI
- Primary DI / UDI-DI
- 07331791015649 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
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
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 EXP Stability 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 |
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Manufacturer
- Manufacturer
- Atos Medical Inc.
Sources (2)
- FDA UDI 9359480c-b0ad-407d-84c5-604bd5378263 36 fields · synced Jul 8, 2026
- EUDAMED 0f5f3664-620e-4103-8506-6370d259eac8 61 fields · synced Jul 8, 2026