Catalog Number

DD+ELISIO-25H

Brand Name

NIPRO ELISIO™ -H HEMODIALYZER

Version/Model Number

ELISIO™-25H

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

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

53ed9aa6-fd65-493f-859f-f445e8fc240a

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 16, 2015

Package DI Number

40383790007137

Quantity per Package

24

Contains DI Package

00383790007139

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case