Duns Number:355470923
Device Description: Provox HME Cap is a dome-shaped titanium ring for rehabilitation after total laryngectomy. Provox HME Cap is a dome-shaped titanium ring for rehabilitation after total laryngectomy. It allows use of the Provox FreeHands HME Cassettes without the Provox FreeHands HME Speech Valve. The front opening of the cap can be occluded manually to speak.
Catalog Number
7730
Brand Name
Provox HME Cap
Version/Model Number
7730
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
BYD
Product Code Name
Condenser, Heat And Moisture (Artificial Nose)
Public Device Record Key
d47592d2-b0d7-4a55-9b4c-3e6d91a6d360
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 |