Catalog Number

-

Brand Name

NXSTAGE CARTRIDGE EXPRESS WITH SPEEDSWAP

Version/Model Number

CAR-535

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

fb091a3e-9ddf-4948-99af-c861188daf7d

Public Version Date

September 17, 2021

Public Version Number

1

DI Record Publish Date

September 09, 2021

Package DI Number

M535CAR5355

Quantity per Package

6

Contains DI Package

M535CAR5350

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipping Box