Duns Number:933721433
Catalog Number
D4-110
Brand Name
CitraPure
Version/Model Number
D4-110
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K062399
Product Code
KPO
Product Code Name
Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Public Device Record Key
2bf2dea7-3eac-4f4c-85e2-13c2e54fd2d5
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 18, 2015
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 104 |