Identity
- Trade Name
- Provox ActiValve Lubricant FDA UDI
- Generic Name
- Tracheoesophageal speech valve, indwelling FDA UDI
- Device Name
- Provox ActiValve Lubricant shall be applied as a thin film on the inner lumen of Provox ActiValve voice prosthesis to help prevent occasional temporary blockage of the valve. FDA UDI
- Model / Reference
- 7149 FDA UDI
- Description
- Provox ActiValve Lubricant shall be applied as a thin film on the inner lumen of Provox ActiValve voice prosthesis to help prevent occasional temporary blockage of the valve. FDA UDI
Identifiers
- Catalog Number
- 7149 FDA UDI
- Primary DI / UDI-DI
- 07331791000515 FDA UDI
- 510(k) Number
- K092593 FDA UDI
- FDA Product Code
- EWL FDA UDI
- GMDN Term
- Tracheoesophageal speech valve, 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
Yes
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
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
Category: Tracheoesophageal speech valve, indwelling
Provox ActiValve Lubricant by Atos Medical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Tracheoesophageal speech valve, indwelling.
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Cleared under the same submission
K092593 also covers:
- Provox ActiValve Light 10 mm — ATOS MEDICAL INC.
- Provox ActiValve Light 12.5 mm — ATOS MEDICAL INC.
- Provox ActiValve Light 4.5 mm — ATOS MEDICAL INC.
- Provox ActiValve Light 6 mm — ATOS MEDICAL INC.
- Provox ActiValve Light 8 mm — ATOS MEDICAL INC.
- Provox ActiValve Strong 10 mm — ATOS MEDICAL INC.
- Provox ActiValve Strong 12.5 mm — ATOS MEDICAL INC.
- Provox ActiValve Strong 4.5 mm — ATOS MEDICAL INC.
- Provox ActiValve Strong 6 mm — ATOS MEDICAL INC.
- Provox ActiValve Strong 8 mm — ATOS MEDICAL INC.
- Provox ActiValve XtraStrong 10 mm — ATOS MEDICAL INC.
- Provox ActiValve XtraStrong 12.5 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 ccf50c84-3d0a-47a8-a1c2-b10e3654ed54 37 fields · synced May 29, 2026