Duns Number:132629788
Device Description: The Aquadex System is indicated for temporary (up to 8 hours) ultrafiltration treatment of The Aquadex System is indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy, and extended (longer than 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy and require hospitalization.
Catalog Number
114157
Brand Name
Blood Circuit Set
Version/Model Number
UF 500-HCT
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 14, 2017
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
f1258b9f-380d-46e3-b0c0-9c09a0f3e93c
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 29, 2015
Package DI Number
37332414112371
Quantity per Package
5
Contains DI Package
07332414112370
Package Discontinue Date
July 14, 2017
Package Status
Not in Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |