Duns Number:068434658
Device Description: Dialysate Additive 15.9 grams Potassium Chloride increases Potassium by 0.5 mEq/L when add Dialysate Additive 15.9 grams Potassium Chloride increases Potassium by 0.5 mEq/L when added to 9.46 liters of concentrate proportioned at 1:44
Catalog Number
PC16
Brand Name
DIASOL
Version/Model Number
PC15.9
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K020231,K020231
Product Code
KPO
Product Code Name
Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Public Device Record Key
54782ee1-8ca6-4f9e-8b9c-f1ba15d7e6b8
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
April 28, 2017
Package DI Number
B467PC159145
Quantity per Package
145
Contains DI Package
B467PC159
Package Discontinue Date
-
Package Status
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. | 36 |