Identity
- Trade Name
- Provox Tracheofix 1 strip beige 38x63 EUDAMEDProvox Tracheofix FDA UDI
- Generic Name
- Tracheostoma protector, single-use FDA UDI
- Device Name
- Provox Tracheofix EUDAMEDProvox 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
- 1434H EUDAMED1 strip beige 38x63 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
- 1434H FDA UDI
- Primary DI / UDI-DI
- 07331791005985 EUDAMEDFDA UDI
- Basic UDI-DI
- 7331791-COM-0-000-0003-58 EUDAMED
- Unit of Use DI
- 07331791016882 EUDAMED
- FDA Product Code
- NAC FDA UDI
- EMDN Code
- R9099 RESPIRATORY AND ANAESTHESIA DEVICES - OTHER EUDAMED
- GMDN Term
- Tracheostoma protector, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4018 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- Not 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
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 — 38 Millimeter FDA UDIWidth — 63 Millimeter FDA UDI
Provox Tracheofix by Atos Medical Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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 605b0bfc-0cf1-4c97-b8b8-75dbd38b21f8 38 fields · synced Jun 18, 2026
- EUDAMED 4560b303-3877-4f50-ae48-cf2a357934cd 61 fields · synced Jun 18, 2026