Catalog Number

7107218

Brand Name

B.BRAUN

Version/Model Number

7107218

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

-

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

K083460,K963440

Product Code

KDI

Product Code Name

Dialyzer, high permeability with or without sealed dialysate system

Public Device Record Key

bea10cdc-2956-4f36-94bb-30c47fc20c9c

Public Version Date

December 18, 2020

Public Version Number

10

DI Record Publish Date

August 09, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-