Duns Number:355470923
Device Description: Provox LaryTube is a holder for devices in the Provox HME System intended for vocal and pu Provox LaryTube is a holder for devices in the Provox HME System intended for vocal and pulmonary rehabilitation after total laryngectomy. For patients with a shrinking tracheostoma it is also used to maintain the tracheostoma for breathing. The Provox LaryTube is intended for single patient use.The model with ring is made for use with or without a voice prosthesis. The model with ring can be fenestrated so that air can go through the voice prosthesis for voice prosthesis users.
Catalog Number
7625
Brand Name
Provox LaryTube
Version/Model Number
8/55 with Ring
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KAC
Product Code Name
Tube, Laryngectomy
Public Device Record Key
fc59ea5a-a254-4f5c-a8f0-87a54d63b96e
Public Version Date
July 13, 2022
Public Version Number
1
DI Record Publish Date
July 05, 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 |