Duns Number:790580182
Device Description: The Aquadex System is indicated for temporary (up to 8 hours) ultrafiltration treatment of
Catalog Number
114157
Brand Name
Blood Circuit Set
Version/Model Number
UF 500
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
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
-
Product Code
KDI
Product Code Name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Public Device Record Key
5ab81bc8-9681-4b1b-9c53-aaab029205bb
Public Version Date
November 25, 2021
Public Version Number
4
DI Record Publish Date
February 22, 2018
Package DI Number
30853072007016
Quantity per Package
5
Contains DI Package
10853072007005
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |