Duns Number:355470923
Device Description: Provox Life LaryTube is a single patient use device intended to provide attachment for Pro Provox Life LaryTube is a single patient use device intended to provide attachment for Provox Life HME and accessories after total laryngectomy. For laryngectomized patients with a shrinking tracheostoma it is also used to maintain the tracheostoma for breathing.Standard model can be fenestrated so that air can go through the voice prosthesis for voice prosthesis users. The holes are punched by using Provox Fenestration Punch according to the Instructions for Use accompanying Provox Fenestration Punch. Standard with Ring model – made for use with or without a voice prosthesis. Can only be attached with a Provox Life Adhesive.
Catalog Number
7428
Brand Name
Provox Life LaryTube
Version/Model Number
12/55 Std 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
4fab0653-6375-4b4a-88fe-2712cd9faff1
Public Version Date
July 15, 2022
Public Version Number
1
DI Record Publish Date
July 07, 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 |