Catalog Number

4109

Brand Name

B.BRAUN

Version/Model Number

4109

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 12, 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

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

-

Product Code

MMY

Product Code Name

LIPOPROTEIN, LOW DENSITY, REMOVAL

Public Device Record Key

a8d3c22e-ecc8-4959-8c1d-187e045e8880

Public Version Date

May 11, 2022

Public Version Number

6

DI Record Publish Date

January 18, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-