Catalog Number

L3-134

Brand Name

CitraPure

Version/Model Number

L3-134

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,K062399

Product Code

KPO

Product Code Name

Dialysate Concentrate For Hemodialysis (Liquid Or Powder)

Public Device Record Key

b5721e40-5e61-4e76-af71-f9b6755c8c0f

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 28, 2015

Package DI Number

10814963021166

Quantity per Package

4

Contains DI Package

00814963021169

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE