Duns Number:828682240
Device Description: ShuntCheck software - Installed on Windows computer; guides user through test procedure, g ShuntCheck software - Installed on Windows computer; guides user through test procedure, gathers and analyzes thermal data, presents results screen with Flow Confirmed or Flow Not Confirmed plus a time-temperature graph
Catalog Number
SCIII SW
Brand Name
ShuntCheck III Software
Version/Model Number
SCIII SW
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
K123554
Product Code
JXG
Product Code Name
Shunt, Central Nervous System And Components
Public Device Record Key
d7a175c0-f51f-41ef-bfc7-c8dd9fd38458
Public Version Date
November 19, 2018
Public Version Number
1
DI Record Publish Date
October 18, 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. | 2 |