Catalog Number

-

Brand Name

NXSTAGE SYSTEM ONE

Version/Model Number

NX1000-3-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"

-

For Single-Use

-

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

KDI

Product Code Name

Dialyzer, High Permeability With Or Without Sealed Dialysate System

Public Device Record Key

f5eaf3c4-895e-4ff7-b851-94586c33fc16

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 16, 2016

Package DI Number

M535NX10003CAN5

Quantity per Package

1

Contains DI Package

M535NX10003CAN0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-