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Provox® FreeHands HME® Speech Valve Membrane Strong
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Provox® FreeHands HME® Speech Valve Membrane Strong FDA UDI
- Generic Name
- Tracheostomy tube speech valve FDA UDI
- Device Name
- The Membrane temporarily closes the Freehands HME Speech Valve, allowing the patient to produce voice without manually occluding the stoma. FDA UDI
- Model / Reference
- Strong FDA UDI
- Description
- The Membrane temporarily closes the Freehands HME Speech Valve, allowing the patient to produce voice without manually occluding the stoma. FDA UDI
Identifiers
- Catalog Number
- 7715 FDA UDI
- Primary DI / UDI-DI
- 07331791002939 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
No
FDA UDI
Over-the-Counter
Yes
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® Speech Valve Membrane 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 223b9243-6df4-47bd-b715-b260f2c869f7 38 fields · synced May 30, 2026