Identity
- Trade Name
- Provox Coming Home USA FDA UDI
- Generic Name
- Tracheostoma protective filter FDA UDI
- Device Name
- Provox Coming Home/Provox Life Coming Home is an assortment of products and information for newly laryngectomized persons. It provides guidance on product use, lung rehabilitation, and stoma care at home. FDA UDI
- Model / Reference
- 8224US FDA UDI
- Description
- Provox Coming Home/Provox Life Coming Home is an assortment of products and information for newly laryngectomized persons. It provides guidance on product use, lung rehabilitation, and stoma care at home. FDA UDI
Identifiers
- Catalog Number
- 8224US FDA UDI
- Primary DI / UDI-DI
- 07331791009334 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
- Not 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
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
MR Safe FDA UDI
Provox Coming Home USA by Atos Medical Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 427f7161-9130-4625-b3e5-6648a43fb8af 37 fields · synced Jun 8, 2026