Catalog Number

SOT4LDPGR3

Brand Name

CARDINAL HEALTH

Version/Model Number

SOT4LDPGR3

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

984fc2e3-140e-4a56-9e9b-443a5b4b2d09

Public Version Date

August 29, 2022

Public Version Number

1

DI Record Publish Date

August 19, 2022

Package DI Number

50195594780577

Quantity per Package

16

Contains DI Package

10195594780579

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE