Duns Number:370482633
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 actue 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
August 31, 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
KPO
Product Code Name
Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Public Device Record Key
4ba1d9e2-d1c5-4a98-853b-5bd4b7efb9e6
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
June 30, 2016
Package DI Number
19349285000205
Quantity per Package
2
Contains DI Package
09349285000208
Package Discontinue Date
August 31, 2017
Package Status
Not in Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |