Identity
- Trade Name
- Provox NID 20, 14 mm FDA UDI
- Generic Name
- Tracheoesophageal speech valve, non-indwelling FDA UDI
- Device Name
- Provox NID is a non-indwelling voice prosthesis for patients who are capable of handling the exchange and maintenance of a voice prosthesis independently of a clinician or physician. FDA UDI
- Model / Reference
- 7115 FDA UDI
- Description
- Provox NID is a non-indwelling voice prosthesis for patients who are capable of handling the exchange and maintenance of a voice prosthesis independently of a clinician or physician. FDA UDI
Identifiers
- Catalog Number
- 7115 FDA UDI
- Primary DI / UDI-DI
- 07331791000379 FDA UDI
- 510(k) Number
- K043138 FDA UDI
- FDA Product Code
- EWL FDA UDI
- GMDN Term
- Tracheoesophageal speech valve, non-indwelling FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.3730 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 14 Millimeter FDA UDI
Category: Tracheoesophageal speech valve, non-indwelling
Provox NID 20, 14 mm by Atos Medical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tracheoesophageal speech valve, non-indwelling.
- InHealth Technologies; Blom-Singer — FREUDENBERG MEDICAL, LLC · Class II
- InHealth Technologies; Blom-Singer — FREUDENBERG MEDICAL, LLC · Class II
- InHealth Technologies; Blom-Singer — FREUDENBERG MEDICAL, LLC · Class II
- InHealth Technologies; Blom-Singer — FREUDENBERG MEDICAL, LLC · Class II
- InHealth Technologies; Blom-Singer — FREUDENBERG MEDICAL, LLC · Class II
- InHealth Technologies; Blom-Singer — FREUDENBERG MEDICAL, LLC · Class II
- InHealth Technologies; Blom-Singer — FREUDENBERG MEDICAL, LLC · Class II
- InHealth Technologies; Blom-Singer — FREUDENBERG MEDICAL, LLC · Class II
Cleared under the same submission
K043138 also covers:
- Provox NID 17, 10 mm — ATOS MEDICAL INC.
- Provox NID 17, 12 mm — ATOS MEDICAL INC.
- Provox NID 17, 14 mm — ATOS MEDICAL INC.
- Provox NID 17, 18 mm — ATOS MEDICAL INC.
- Provox NID 17, 6 mm — ATOS MEDICAL INC.
- Provox NID 17, 8 mm — ATOS MEDICAL INC.
- Provox NID 20, 10 mm — ATOS MEDICAL INC.
- Provox NID 20, 12 mm — ATOS MEDICAL INC.
- Provox NID 20, 18 mm — ATOS MEDICAL INC.
- Provox NID 20, 6 mm — ATOS MEDICAL INC.
- Provox NID 20, 8 mm — ATOS MEDICAL INC.
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 f3fed727-b32c-4a0c-8bf3-2bb1bbe501f2 38 fields · synced May 30, 2026