CARDINAL HEALTH - OPEN HEART PART 2 - Cardinal Health 200, LLC

Duns Number:961027315

Device Description: OPEN HEART PART 2

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More Product Details

Catalog Number

SCV5DOHW10

Brand Name

CARDINAL HEALTH

Version/Model Number

SCV5DOHW10

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)

-

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 Details

Product Code

OEZ

Product Code Name

Cardiovascular procedure kit

Device Record Status

Public Device Record Key

a47e8bee-295b-4877-946c-4294e137f611

Public Version Date

May 28, 2019

Public Version Number

1

DI Record Publish Date

May 20, 2019

Additional Identifiers

Package DI Number

50888439505854

Quantity per Package

1

Contains DI Package

10888439505856

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