Identity
- Trade Name
- Provox XtraFlow HME (30 pcs) FDA UDI
- Generic Name
- Tracheostoma protective filter FDA UDI
- Device Name
- The Provox XtraHME Cassette is a single use, specialized device intended for patients breathing through a tracheostoma. It is a heat and moisture exchanger (HME) that heats and humidifies inhaled air by retaining heat and moist from exhaled air in the device. It partially restores lost breathing resistance. For patients with a voice prosthesis or surgical speech fistula it may also facilitate voicing. FDA UDI
- Model / Reference
- 7291 FDA UDI
- Description
- The Provox XtraHME Cassette is a single use, specialized device intended for patients breathing through a tracheostoma. It is a heat and moisture exchanger (HME) that heats and humidifies inhaled air by retaining heat and moist from exhaled air in the device. It partially restores lost breathing resistance. For patients with a voice prosthesis or surgical speech fistula it may also facilitate voicing. FDA UDI
Identifiers
- Catalog Number
- 7291 FDA UDI
- Primary DI / UDI-DI
- 07331791005909 FDA UDI
- FDA Product Code
- BYD FDA UDI
- GMDN Term
- Tracheostoma protective filter FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5375 FDA UDI
- Commercial Distribution
- 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
Category: Tracheostoma protective filter
Provox XtraFlow HME (30 pcs) by Atos Medical Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 f347cef0-fffb-4a2c-a10c-b2be0771bbeb 36 fields · synced May 31, 2026