Catalog Number

-

Brand Name

Optiflux®

Version/Model Number

0500318E

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

12b863b5-3a49-4e22-9def-f1bd6a01dc46

Public Version Date

October 21, 2019

Public Version Number

4

DI Record Publish Date

September 24, 2015

Package DI Number

10840861100153

Quantity per Package

12

Contains DI Package

00840861100156

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-