Duns Number:355470923
Device Description: The Provox FreeHands FlexiVoice consists of two parts assembled together, a speaking valve The Provox FreeHands FlexiVoice consists of two parts assembled together, a speaking valve for single patient use and a disposable HME cassette. The speaking valve has two modes; Automatic Speaking Mode and Locked Mode.
Catalog Number
7757
Brand Name
Provox® FreeHands FlexiVoice™ Set Plus
Version/Model Number
7757
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K141380
Product Code
EWL
Product Code Name
Prosthesis, Laryngeal (Taub)
Public Device Record Key
ba869501-c9e0-4a59-8724-c7ca3adf469a
Public Version Date
August 23, 2018
Public Version Number
4
DI Record Publish Date
September 11, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 119 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 169 |