Catalog Number

C-129

Brand Name

RenalPure

Version/Model Number

C-129

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

K954527,K954527

Product Code

KPO

Product Code Name

Dialysate Concentrate For Hemodialysis (Liquid Or Powder)

Public Device Record Key

a27cb9e7-285e-4858-98c4-84db7501b578

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 08, 2017

Package DI Number

10814963021357

Quantity per Package

4

Contains DI Package

00814963021350

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case