Duns Number:370482633
Device Description: Accusol 30 2K+ Solution is indicated for use as dialysis solutions in Continuous Renal Rep Accusol 30 2K+ Solution is indicated for use as dialysis solutions in Continuous Renal Replacement Therapy.
Catalog Number
5B9251
Brand Name
ACCUSOL Dialysis Solution for CRRT
Version/Model Number
30 2K+
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 30, 2018
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
345636cb-eacc-4a54-a8b0-91f7f5524d9c
Public Version Date
October 22, 2018
Public Version Number
4
DI Record Publish Date
June 30, 2016
Package DI Number
19349285000182
Quantity per Package
4
Contains DI Package
09349285000185
Package Discontinue Date
September 30, 2018
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 |