Duns Number:105714027
Device Description: A pole-mounted wireless charging dock for the TwitchView™ Monitor that simplifies the clin A pole-mounted wireless charging dock for the TwitchView™ Monitor that simplifies the clinical workflow by connecting directly to your facility’s electronic medical record or through middleware solutions.
Catalog Number
-
Brand Name
TwitchView™
Version/Model Number
Charging Dock v1
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
K172843
Product Code
KOI
Product Code Name
Stimulator, Nerve, Peripheral, Electric
Public Device Record Key
e3d34ffc-5475-45fd-a6d5-4b7d6027e81a
Public Version Date
February 06, 2020
Public Version Number
2
DI Record Publish Date
September 05, 2018
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |