Duns Number:355470923
Device Description: The Provox BasePlate Adaptor is an accessory product for rehabilitation after total laryng The Provox BasePlate Adaptor is an accessory product for rehabilitation after total laryngectomy. It allows attaching medical devices with ISO 15mm standard connector to a tracheostoma by fitting it into a Provox Adhesive base plate, Provox LaryButton or Provox LaryTube. A typical example would be to attach an HME with built-in oxygen adapter (TrachPhone). For single patient use.
Catalog Number
-
Brand Name
Provox® BasePlate Adaptor
Version/Model Number
7263
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
K014102
Product Code
JOH
Product Code Name
Tube Tracheostomy And Tube Cuff
Public Device Record Key
694f0ab1-ba4e-4030-92d9-f5e83b041876
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 11, 2016
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 |