Duns Number:752219480
Device Description: ProEX Telehealth Hub System FSC2 PAL - CLINICIAN v2
Catalog Number
-
Brand Name
Visionflex
Version/Model Number
VFPROEX22.02
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OUG
Product Code Name
Medical Device Data System
Public Device Record Key
57481d03-6e07-455d-8126-e6b9116a6586
Public Version Date
August 25, 2020
Public Version Number
1
DI Record Publish Date
August 17, 2020
Package DI Number
09352527000690
Quantity per Package
1
Contains DI Package
09352527000560
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 3 |