Duns Number:005146311
Device Description: Premixed Dialysate for Hemodiafiltration is indicated for acute dialysis modalities that e Premixed Dialysate for Hemodiafiltration is indicated for acute dialysis modalities that employ hemodiafiltration, such as continuous arteriovenous hemodiafiltration (CAVHD) and Continuous Venous-Venous Hemodiafiltration (CVVHD), when treatment of acute renal failure patients with hypervolemia and uremia requires high solute clearance.
Catalog Number
5B7860
Brand Name
Premixed Dialysate for Hemodiafiltration
Version/Model Number
5B7860
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 17, 2015
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
KPO
Product Code Name
DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
Public Device Record Key
c7509812-f4c5-41b6-90d2-99358563111a
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 24, 2015
Package DI Number
50085412007385
Quantity per Package
2
Contains DI Package
00085412007380
Package Discontinue Date
December 17, 2015
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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 358 |