Duns Number:370482633
Device Description: Accusol 35 4K+ Solution is indicated for use as a dialysis solution in Continuous Renal Re Accusol 35 4K+ Solution is indicated for use as a dialysis solution in Continuous Renal Replacement Therapy.
Catalog Number
5B9248
Brand Name
ACCUSOL Dialysis Solution for CRRT
Version/Model Number
35 4K+
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 31, 2022
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
K041428,K041428
Product Code
KPO
Product Code Name
Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Public Device Record Key
8bf94465-8f57-48ad-9042-b42abd2386a4
Public Version Date
July 04, 2022
Public Version Number
4
DI Record Publish Date
June 30, 2016
Package DI Number
19349285000151
Quantity per Package
4
Contains DI Package
09349285000154
Package Discontinue Date
May 31, 2022
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 |