Catalog Number

104311

Brand Name

POLYFLUX

Version/Model Number

10LR

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 09, 2021

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

-

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

FJI

Product Code Name

DIALYZER, CAPILLARY, HOLLOW FIBER

Public Device Record Key

24ea892e-f3e2-49ef-9fb2-6240d9ebc8cf

Public Version Date

September 23, 2021

Public Version Number

5

DI Record Publish Date

October 12, 2015

Package DI Number

37332414047109

Quantity per Package

16

Contains DI Package

07332414047108

Package Discontinue Date

April 09, 2021

Package Status

Not in Commercial Distribution

Package Type

CASE