Duns Number:005146311
Device Description: Accusol 35 4K+ Solution is indicated for use as dialysis solutions in Continuous Renal Rep Accusol 35 4K+ Solution is indicated for use as dialysis solutions 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
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
95c2ba20-6f68-4d39-80c9-1a3d56ecb1ca
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 24, 2015
Package DI Number
50085412079115
Quantity per Package
4
Contains DI Package
00085412079110
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 |