Catalog Number

SAN12EPUMT

Brand Name

CARDINAL HEALTH

Version/Model Number

SAN12EPUMT

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

OEZ

Product Code Name

Cardiovascular procedure kit

Public Device Record Key

33f68cc9-ef65-4e70-aa34-4716e88ca7cc

Public Version Date

January 29, 2020

Public Version Number

1

DI Record Publish Date

January 21, 2020

Package DI Number

50888439626030

Quantity per Package

3

Contains DI Package

10888439626032

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE