Duns Number:089176922
Device Description: The Aqueduct SED Console is part of the Aqueduct SED System for monitoring of intracranial The Aqueduct SED Console is part of the Aqueduct SED System for monitoring of intracranial pressure (ICP) and draining and monitoring of CSF flow from the lateral ventricles.
Catalog Number
-
Brand Name
Aqueduct SED
Version/Model Number
ACC-CON-101
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
MR Unsafe
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
JXG
Product Code Name
Shunt, Central Nervous System And Components
Public Device Record Key
0001af27-18c6-49f8-a89b-4363091cbef4
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 27, 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. | 11 |