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Freevent XtraCare Mini White (5 pcs)
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 7789
Identity
- Trade Name
- Freevent XtraCare White (5 pcs) EUDAMEDFDA UDIFreevent XtraCare Mini White (5 pcs) FDA UDI
- Generic Name
- Tracheostoma protective filter FDA UDI
- Device Name
- Freevent XtraCare EUDAMEDFreevent XtraCare Mini is a single use Heat and Moisture Exchanger with electrostatic filter (HMEF) that condition and filter inhaled air in patients spontaneously breathing through a tracheostoma. FDA UDIFreevent XtraCare and Freevent XtraCare Mini are single use Heat and Moisture Exchangers with electrostatic filters (HMEF) that condition and filter inhaled air in patients spontaneously breathing through a tracheostoma FDA UDI
- Model / Reference
- 7789 EUDAMEDFDA UDI8008 FDA UDI
- Description
- Freevent XtraCare Mini is a single use Heat and Moisture Exchanger with electrostatic filter (HMEF) that condition and filter inhaled air in patients spontaneously breathing through a tracheostoma. FDA UDIFreevent XtraCare and Freevent XtraCare Mini are single use Heat and Moisture Exchangers with electrostatic filters (HMEF) that condition and filter inhaled air in patients spontaneously breathing through a tracheostoma FDA UDI
Identifiers
- Catalog Number
- 8008 FDA UDI7789 FDA UDI
- Primary DI / UDI-DI
- 07331791008979 EUDAMEDFDA UDI07331791014932 FDA UDI
- Basic UDI-DI
- 7331791-HME-0-000-0004-XM EUDAMED
- Unit of Use DI
- 07331791016578 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
- Belgium 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
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
Freevent XtraCare Mini White (5 pcs) by Atos Medical Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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
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 (3)
- FDA UDI d29541e5-88b2-4a4e-9bd4-d7d6a54a8122 36 fields · synced Jul 26, 2026
- FDA UDI ad8a9c93-ea0c-4562-afc5-881eb7faa8f5 36 fields · synced May 30, 2026
- EUDAMED 31b024c3-466d-4183-8370-cf7d285c42c2 61 fields · synced Jul 26, 2026