CARDINAL HEALTH - KIT,OPEN HEART,HILLCREST - Cardinal Health 200, LLC

Duns Number:961027315

Device Description: KIT,OPEN HEART,HILLCREST

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

PC29OH07O

Brand Name

CARDINAL HEALTH

Version/Model Number

PC29OH07O

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

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 Details

Product Code

OEZ

Product Code Name

Cardiovascular procedure kit

Device Record Status

Public Device Record Key

e056c490-59a0-4fa7-a2d0-56cf4c522806

Public Version Date

July 17, 2018

Public Version Number

3

DI Record Publish Date

September 02, 2015

Additional Identifiers

Package DI Number

50887488012948

Quantity per Package

1

Contains DI Package

00887488012943

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"CARDINAL HEALTH 200, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 101686
2 A medical device with a moderate to high risk that requires special controls. 139430
3 A medical device with high risk that requires premarket approval 8
U Unclassified 40