Duns Number:355470923
Device Description: Provox Flush is intended to be used to flush drinking water or air through the inner lumen Provox Flush is intended to be used to flush drinking water or air through the inner lumen of a Provox voice prosthesis for cleaning purposes. The Flush isintended for both home and clinical use by patient or clinician. Single patient re-use.
Catalog Number
8109
Brand Name
Provox Flush
Version/Model Number
8109
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LRC
Product Code Name
Instrument, Ent Manual Surgical
Public Device Record Key
efda058a-5123-4dc4-9b9a-efdbaae802b0
Public Version Date
July 20, 2022
Public Version Number
1
DI Record Publish Date
July 12, 2022
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 |