Catalog Number

-

Brand Name

NxStage PureFlow Solution

Version/Model Number

RFP-211-WW

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

0fb783b3-baec-4c01-bdf7-102cba6c19e2

Public Version Date

November 01, 2018

Public Version Number

1

DI Record Publish Date

October 01, 2018

Package DI Number

M535RFP211WW5

Quantity per Package

2

Contains DI Package

M535RFP211WW0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipping Box