Catalog Number

613400

Brand Name

B.BRAUN

Version/Model Number

613400

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 11, 2016

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"

Yes

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

K083873,K083873

Product Code

LJS

Product Code Name

Catheter,intravascular,therapeutic,long-term greater than 30 days

Public Device Record Key

5840ba61-46ff-4035-a5de-f7e98343bfd9

Public Version Date

February 19, 2021

Public Version Number

6

DI Record Publish Date

July 22, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-