Catalog Number

-

Brand Name

Optiflux®

Version/Model Number

0500320N

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

aa6d363b-9df8-4cd8-8fde-e6d94160d012

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 24, 2015

Package DI Number

10840861100139

Quantity per Package

12

Contains DI Package

00840861100132

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-