Catalog Number

-

Brand Name

NXSTAGE TPE CARTRIDGE

Version/Model Number

CAR-510-B

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

KDI

Product Code Name

Dialyzer, High Permeability With Or Without Sealed Dialysate System

Public Device Record Key

484df07a-5803-492d-b850-d937e6066533

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 01, 2015

Package DI Number

M535CAR510B5

Quantity per Package

6

Contains DI Package

M535CAR510B0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-