Identity
- Trade Name
- Provox Life LP Kit 17 - LT 10/55-2HTTP FDA UDI
- Generic Name
- Tracheostoma protective filter FDA UDI
- Device Name
- Provox Laryngectomy Kits provide all-in-one packaging for immediate post-operative 24/7 pulmonary rehabilitation and the option for ready-to-use surgical placement. The kits feature Provox Heat and Moisture Exchangers (HMEs) – approved for 24-hour use. These products are packed in a box and contain marketing materials and a mix of the following final products (configuration dependent): Provox Life LaryTube, Provox Life Home HME, Provox Life Night HME, Freevent Neckband two-piece L, Provox TubeBrush, Provox Life Shower, Provox SolaTone Plus, TruTone Plus FDA UDI
- Model / Reference
- 6146 FDA UDI
- Description
- Provox Laryngectomy Kits provide all-in-one packaging for immediate post-operative 24/7 pulmonary rehabilitation and the option for ready-to-use surgical placement. The kits feature Provox Heat and Moisture Exchangers (HMEs) – approved for 24-hour use. These products are packed in a box and contain marketing materials and a mix of the following final products (configuration dependent): Provox Life LaryTube, Provox Life Home HME, Provox Life Night HME, Freevent Neckband two-piece L, Provox TubeBrush, Provox Life Shower, Provox SolaTone Plus, TruTone Plus FDA UDI
Identifiers
- Catalog Number
- 6146 FDA UDI
- Primary DI / UDI-DI
- 07331791016158 FDA UDI
- FDA Product Code
- OGW FDA UDI
- GMDN Term
- Tracheostoma protective filter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5800 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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: Tracheostomy tube, non-reinforced, non-customized, reusableTracheostomy tube neck holder, single-useTracheostoma protective filterAirway device cleaning utensil, noninvasive, reusable
Provox Life LP Kit 17 - LT 10/55-2HTTP by Atos Medical Inc. — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Atos Medical Inc.
Sources (1)
- FDA UDI 9eaa6398-dd5f-4818-80f7-7680743eb500 36 fields · synced May 30, 2026