Identity
- Trade Name
- Provox® FreeHands HME® Replacement Device Strong FDA UDI
- Generic Name
- Tracheostomy tube speech valve FDA UDI
- Device Name
- PROVOX® FreeHands HME is an automatic, reusable multi-magnet valve system that keeps the valve closed during speech. FDA UDI
- Model / Reference
- Strong FDA UDI
- Description
- PROVOX® FreeHands HME is an automatic, reusable multi-magnet valve system that keeps the valve closed during speech. FDA UDI
Identifiers
- Catalog Number
- 7721 FDA UDI
- Primary DI / UDI-DI
- 07331791002991 FDA UDI
- 510(k) Number
- K022125 FDA UDI
- FDA Product Code
- EWL FDA UDI
- GMDN Term
- Tracheostomy tube speech valve FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.3730 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Provox® FreeHands HME® Replacement Device Strong by Atos Medical Inc. — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Atos Medical Inc.
Sources (1)
- FDA UDI 1918f6d4-b789-4980-93c9-57b63ddb3dde 38 fields · synced May 30, 2026