Catalog Number

SNU11OOSBD

Brand Name

CARDINAL HEALTH

Version/Model Number

SNU11OOSBD

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"

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

-

Product Code

FKG

Product Code Name

TRAY, START/STOP (INCLUDING CONTENTS), DIALYSIS

Public Device Record Key

f033deb6-f7a1-49b1-9571-88c38bd02a94

Public Version Date

July 17, 2018

Public Version Number

3

DI Record Publish Date

July 05, 2016

Package DI Number

50887488509011

Quantity per Package

24

Contains DI Package

10887488509013

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE