Identity
- Trade Name
- Provox® FreeHands HME® Casette FDA UDI
- Generic Name
- Tracheostoma protective filter FDA UDI
- Device Name
- The Freehands HME Cassette heats and humidifies the inhaled air and partially restores breathing resistance. The FreeHands HME Cassette should only be used with the Provox Freehands automatic speech valve. FDA UDI
- Model / Reference
- 7712 FDA UDI
- Description
- The Freehands HME Cassette heats and humidifies the inhaled air and partially restores breathing resistance. The FreeHands HME Cassette should only be used with the Provox Freehands automatic speech valve. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07331791002892 FDA UDI
- FDA Product Code
- EWL FDA UDI
- GMDN Term
- Tracheostoma protective filter 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
No
FDA UDI
Combination Product
No
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 Safe FDA UDI
Provox® FreeHands HME® Casette 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 bce39e6d-7fd0-4083-8b98-753805f023b1 36 fields · synced May 30, 2026