Duns Number:828682240
Device Description: Data Acquisition Unit (DAQ) - an electronic connector box which connects a Windows compute Data Acquisition Unit (DAQ) - an electronic connector box which connects a Windows computer running ShuntCheck software to the ShuntCheck Thermosensor
Catalog Number
DAQ-1
Brand Name
ShuntCheck III DAQ
Version/Model Number
DAQ-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
K123554
Product Code
JXG
Product Code Name
Shunt, Central Nervous System And Components
Public Device Record Key
a3c1db3c-0ac2-45b0-a439-b60963c08b1c
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 |