Identity
- Trade Name
- Freevent XtraCare Blue (5 pcs) EUDAMEDFDA UDI
- Generic Name
- Tracheostoma protective filter FDA UDI
- Device Name
- Freevent XtraCare EUDAMEDFreevent 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
- 7788 EUDAMEDFDA UDI
- Description
- Freevent 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
- 7788 FDA UDI
- Primary DI / UDI-DI
- 07331791008962 EUDAMEDFDA UDI
- Basic UDI-DI
- 7331791-HME-0-000-0004-XM EUDAMED
- Unit of Use DI
- 07331791016561 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
- Czechia 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 Blue (5 pcs) by Atos Medical Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 15e08aa2-16fa-4a51-8345-f7ae0813ae40 36 fields · synced Jul 9, 2026
- EUDAMED c236542b-1994-465f-8177-34d1fb412847 61 fields · synced Jul 9, 2026