Duns Number:362997926
Device Description: USB Charging Cable for use with ScanVision, FlexVision, ThermoVision
Catalog Number
-
Brand Name
USB Charging Cable
Version/Model Number
PB-220-1
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K123399
Product Code
HCC
Product Code Name
Device, Biofeedback
Public Device Record Key
0ac6a548-2f42-49aa-8a91-d56c10e409c5
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
December 13, 2017
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 | 43 |