Duns Number:790580182
Device Description: The Aquadex SmartFlow System is indicated for: Continuous ultrafiltration therapy for temp The Aquadex SmartFlow System is indicated for: Continuous ultrafiltration therapy for temporary (up to 8 hours) or extended (longer than 8 hours in patients who require hospitalization) use in adult and pediatric patients weighing 20 kilograms or more whose fluid overload is unresponsive to medical management, including diuretics. All treatments must be administered within an outpatient or inpatient clinical setting by a healthcare provider, under physician prescription, both of whom having received training in extracorporeal therapies.
Catalog Number
120100
Brand Name
Aquadex SmartFlow Console
Version/Model Number
120100
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
-
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
K192756
Product Code
KDI
Product Code Name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Public Device Record Key
4f37d703-6e13-419a-a994-2cb15120a818
Public Version Date
November 25, 2021
Public Version Number
2
DI Record Publish Date
March 03, 2020
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. | 6 |