Duns Number:089176922
Device Description: The Aqueduct SED Drain Bag interfaces with the Aqueduct SED Cartridge to collect CSF.
Catalog Number
-
Brand Name
Aqueduct SED
Version/Model Number
ACC-BAG-100
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
MR Conditional
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
Yes
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
K161605,K161605
Product Code
JXG
Product Code Name
Shunt, Central Nervous System And Components
Public Device Record Key
f1526e8a-46b3-470e-b72b-24aa004d2737
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
March 20, 2017
Package DI Number
ACCBAG100
Quantity per Package
10
Contains DI Package
ACCBAG000
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shelf Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 11 |