Catalog Number

CSG7

Brand Name

CitriSol

Version/Model Number

CS80225-10200

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

K130511,K130511,K130511

Product Code

KPO

Product Code Name

Dialysate Concentrate For Hemodialysis (Liquid Or Powder)

Public Device Record Key

ddf6237c-a0df-44cc-9b07-ee5f9d4b073d

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

March 31, 2017

Package DI Number

B467CS80225102004

Quantity per Package

4

Contains DI Package

B467CS8022510200

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE