Identity
- Trade Name
- Provox Tracheofix FDA UDI
- Generic Name
- Tracheostoma protector, single-use FDA UDI
- Device Name
- Provox Tracheofix is a single-use foam protector intended to absorb secretions and to provide protection and aesthetic coverage of the tracheostoma. FDA UDI
- Model / Reference
- 1 strip beige 70x70 FDA UDI
- Description
- Provox Tracheofix is a single-use foam protector intended to absorb secretions and to provide protection and aesthetic coverage of the tracheostoma. FDA UDI
Identifiers
- Catalog Number
- 1430H FDA UDI
- Primary DI / UDI-DI
- 07331791006777 FDA UDI
- FDA Product Code
- NAC FDA UDI
- GMDN Term
- Tracheostoma protector, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4018 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
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
MR Safe FDA UDI
Dimensions & Sizes
- Size
- Height — 70 Millimeter FDA UDIWidth — 70 Millimeter FDA UDI
Provox Tracheofix 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 61ade000-8004-46d9-bf6b-3b551c1a3454 38 fields · synced May 30, 2026