Catalog Number

-

Brand Name

Optiflux®

Version/Model Number

0500308E

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

K043244,K043244

Product Code

KDI

Product Code Name

Dialyzer, high permeability with or without sealed dialysate system

Public Device Record Key

13b647e4-3835-497a-a2c6-ffdfa01bb913

Public Version Date

November 01, 2021

Public Version Number

3

DI Record Publish Date

September 24, 2015

Package DI Number

10840861100085

Quantity per Package

12

Contains DI Package

00840861100088

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-