Duns Number:005146311
Device Description: The product is a sterile dialysis solution intended for treatment of acute kidney disease The product is a sterile dialysis solution intended for treatment of acute kidney disease (renal failure) using Continuous Renal Replacement Therapies, such as continuous hemodialysis and hemodiafiltration aimed at normalizing the composition of the blood. The product may also be used in case of drug poisoning with dialyzable or filterable substances.
Catalog Number
113915
Brand Name
PrismaSATE
Version/Model Number
113915
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"
Yes
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
K013448,K013448
Product Code
KPO
Product Code Name
DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
Public Device Record Key
14e48ddb-7729-4679-946e-3ea644966504
Public Version Date
October 11, 2022
Public Version Number
4
DI Record Publish Date
September 24, 2015
Package DI Number
37332414108589
Quantity per Package
2
Contains DI Package
07332414108588
Package Discontinue Date
-
Package Status
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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 358 |