Duns Number:355470923
Device Description: Provox TubeHolder is used for extra support for Provox LaryButton and Provox LaryTube. It Provox TubeHolder is used for extra support for Provox LaryButton and Provox LaryTube. It goes around the neck of the user and the ends are attached to the “ears” of the LaryTube/LaryButton. The Tubeholder is adjustable in length using a Velcro® connection and allows the user to cut the band to suitable length.
Catalog Number
7668
Brand Name
Provox TubeHolder
Version/Model Number
7668
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CBH
Product Code Name
Device, Fixation, Tracheal Tube
Public Device Record Key
5d53784d-99f7-473e-8f15-70209cfffb35
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 |