Duns Number:089176922
Device Description: The Aqueduct SED Drain Bag Holder interfaces with the Aqueduct SED Drain Bag (ACCBAG000) w The Aqueduct SED Drain Bag Holder interfaces with the Aqueduct SED Drain Bag (ACCBAG000) when in use with the Aqueduct SED Console (ACCCON101).
Catalog Number
-
Brand Name
Aqueduct SED
Version/Model Number
ACC-HLD-100
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
K161605
Product Code
JXG
Product Code Name
Shunt, Central Nervous System And Components
Public Device Record Key
b8fb07bd-c31e-44dd-85ff-9af8cf25bc0e
Public Version Date
June 07, 2019
Public Version Number
4
DI Record Publish Date
March 20, 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 |