Catalog Number

C-131

Brand Name

RenalPure

Version/Model Number

C-131

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

a9d7cc12-ca5b-4b81-82f0-0716c049543e

Public Version Date

June 25, 2019

Public Version Number

1

DI Record Publish Date

June 17, 2019

Package DI Number

10814963021487

Quantity per Package

4

Contains DI Package

00814963021480

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-