Identity
- Trade Name
- Freevent O2 Adaptor (10 pcs) FDA UDI
- Generic Name
- Tracheostoma protective filter FDA UDI
- Device Name
- Freevent O2 Adaptor and Freevent O2 Adaptor Mini are single use accessories used together with Freevent XtraCare or Freevent XtraCare Mini respectively. The devices are intended to enable additional oxygen supply for patients breathing through a tracheostoma during use of Freevent XtraCare and Freevent XtraCare Mini. FDA UDI
- Model / Reference
- 7769 FDA UDI
- Description
- Freevent O2 Adaptor and Freevent O2 Adaptor Mini are single use accessories used together with Freevent XtraCare or Freevent XtraCare Mini respectively. The devices are intended to enable additional oxygen supply for patients breathing through a tracheostoma during use of Freevent XtraCare and Freevent XtraCare Mini. FDA UDI
Identifiers
- Catalog Number
- 7769 FDA UDI
- Primary DI / UDI-DI
- 07331791008986 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
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 O2 Adaptor (10 pcs) by Atos Medical Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Atos Medical Inc.
Sources (1)
- FDA UDI e9ea12a2-19fa-4c7e-8b4e-052c9cb91beb 36 fields · synced May 30, 2026