Catalog Number

104176

Brand Name

Polyflux

Version/Model Number

21L

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

K043342,K043342

Product Code

FJI

Product Code Name

DIALYZER, CAPILLARY, HOLLOW FIBER

Public Device Record Key

bb5f947c-b7ca-46e1-a83f-3d6cff1d6db8

Public Version Date

October 11, 2022

Public Version Number

6

DI Record Publish Date

October 12, 2015

Package DI Number

37332414048182

Quantity per Package

24

Contains DI Package

07332414048181

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE