Catalog Number

-

Brand Name

BBraun

Version/Model Number

375216

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 11, 2020

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

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

LRS

Product Code Name

I.V. start kit

Public Device Record Key

731115e6-6ae6-47d6-9e9b-11a679f90b96

Public Version Date

September 14, 2020

Public Version Number

2

DI Record Publish Date

April 16, 2020

Package DI Number

20809160282431

Quantity per Package

20

Contains DI Package

10809160282434

Package Discontinue Date

September 11, 2020

Package Status

Not in Commercial Distribution

Package Type

-