Duns Number:089176922
Device Description: The Aqueduct Smart External Drain Kit is a convenience kit of the re-usable portions of th The Aqueduct Smart External Drain Kit is a convenience kit of the re-usable portions of the Aqueduct SED System. The Aqueduct SED system is a collection of devices for Monitoring of intracranial pressure (ICP) and draining and monitoring of CSF flow from the lateral ventricles.This kit contains ACCCON101 and ACCHLD100.
Catalog Number
-
Brand Name
Aqueduct SED
Version/Model Number
ACC-KIT-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
b274e387-f847-4d72-b98f-274faa4d3023
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 |