Catalog Number

-

Brand Name

PUREFLOW DIALYSATE

Version/Model Number

RFP-209-CAN

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"

Yes

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

-

Product Code

KPO

Product Code Name

Dialysate Concentrate For Hemodialysis (Liquid Or Powder)

Public Device Record Key

65557897-7a6b-4c35-bcb0-3b673131241e

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

July 21, 2016

Package DI Number

M535RFP209CAN5

Quantity per Package

2

Contains DI Package

M535RFP209CAN0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-