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Provox Vega Plug 22.5

FDA UDI

Class II (US FDA UDI)

by Atos Medical Inc.

Identity

Trade Name
Provox Vega Plug 22.5 FDA UDI
Generic Name
Tracheoesophageal speech valve occluder, non-valved FDA UDI
Device Name
The Provox Vega Plug is a first-aid tool for temporarily stopping leakage through a Provox Vega voice prosthesis. The device is inserted into the opening of the Provox Vega voice prosthesis and hence blocking any leakage through the valve. FDA UDI
Model / Reference
8139 FDA UDI
Description
The Provox Vega Plug is a first-aid tool for temporarily stopping leakage through a Provox Vega voice prosthesis. The device is inserted into the opening of the Provox Vega voice prosthesis and hence blocking any leakage through the valve. FDA UDI

Identifiers

Catalog Number
8139 FDA UDI
Primary DI / UDI-DI
07331791005961 FDA UDI
510(k) Number
K940638 FDA UDI
FDA Product Code
EWL FDA UDI
GMDN Term
Tracheoesophageal speech valve occluder, non-valved 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

No

FDA UDI

Over-the-Counter

Yes

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

Category: Tracheoesophageal speech valve occluder, non-valved

Provox Vega Plug 22.5 by Atos Medical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Tracheoesophageal speech valve occluder, non-valved.

Cleared under the same submission

K940638 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Atos Medical Inc.

Sources (1)

  • FDA UDI 921666df-d667-4936-acfe-e2fa36a28f6b 38 fields · synced Jun 8, 2026