Optiflux® - F16NR Optiflux Dialyzer / Low Flux / Polysulfone - Fresenius Medical Care Holdings, Inc.

Duns Number:958291411

Device Description: F16NR Optiflux Dialyzer / Low Flux / Polysulfone / 1.5 m2 / Ebeam / Single Use / 84 mL

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More Product Details

Catalog Number

-

Brand Name

Optiflux®

Version/Model Number

0500306E

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

KDI

Product Code Name

Dialyzer, high permeability with or without sealed dialysate system

Device Record Status

Public Device Record Key

26e4500b-ad43-4876-ba50-56750592dfea

Public Version Date

November 01, 2021

Public Version Number

3

DI Record Publish Date

September 24, 2015

Additional Identifiers

Package DI Number

10840861100078

Quantity per Package

12

Contains DI Package

00840861100071

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"FRESENIUS MEDICAL CARE HOLDINGS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 65