Duns Number:078675640
Device Description: Varia-NCI accesses data from Varia TCD, a digital Transcranial Doppler (TCD) Ultrasound de Varia-NCI accesses data from Varia TCD, a digital Transcranial Doppler (TCD) Ultrasound device. Varia-NCI is an intuitive software program that provides clinicians information on a patient’s cerebrovascular regulation by reporting key physiologic parameters, including the Neurovascular Complexity Index (NCI). Through high performance analytical processing of a TCD recording, it delivers quantitative Cerebral Blood Flow Velocity (CBFV) variability results to clinicians managing head trauma. Varia-NCI is an accessory application to the Varia TCD device.Software only device and accessory to Varia TCD.
Catalog Number
7798
Brand Name
Varia-NCI
Version/Model Number
1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
Product Code
IYN
Product Code Name
System, Imaging, Pulsed Doppler, Ultrasonic
Public Device Record Key
13382fe9-4c2b-4e63-a4cf-bce59eb28543
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
January 24, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |