Catalog Number

-

Brand Name

NxStage PureFlow B Solution

Version/Model Number

RFP-404

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

3619a1da-698e-4077-9116-233e74a87e60

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 01, 2015

Package DI Number

M535RFP4045

Quantity per Package

2

Contains DI Package

M535RFP4040

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-