POLYFLUX - Polyflux R is intended for use in hemodialysis - Gambro Dialysatoren GmbH

Duns Number:316150549

Device Description: Polyflux R is intended for use in hemodialysis for the treatment of chronic and acute rena Polyflux R is intended for use in hemodialysis for the treatment of chronic and acute renal failure Polyflux R may be reprocessed for reuse on the same patient

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More Product Details

Catalog Number

100691

Brand Name

POLYFLUX

Version/Model Number

21R

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 09, 2021

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

-

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

K043342,K043342

Product Code Details

Product Code

FJI

Product Code Name

DIALYZER, CAPILLARY, HOLLOW FIBER

Device Record Status

Public Device Record Key

c8fea08e-b30e-48d2-a202-5eac3e12b0d9

Public Version Date

September 23, 2021

Public Version Number

5

DI Record Publish Date

October 12, 2015

Additional Identifiers

Package DI Number

37332414031788

Quantity per Package

16

Contains DI Package

07332414031787

Package Discontinue Date

April 09, 2021

Package Status

Not in Commercial Distribution

Package Type

CASE

"GAMBRO DIALYSATOREN GMBH" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 23