CARDINAL HEALTH - STERILE VASCULAR PACK - Cardinal Health 200, LLC

Duns Number:961027315

Device Description: STERILE VASCULAR PACK

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More Product Details

Catalog Number

SCV11VASCD

Brand Name

CARDINAL HEALTH

Version/Model Number

SCV11VASCD

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

fc3c430a-9224-48dc-b592-d5479e8c101f

Public Version Date

July 17, 2018

Public Version Number

3

DI Record Publish Date

August 02, 2016

Additional Identifiers

Package DI Number

50885425999000

Quantity per Package

5

Contains DI Package

10885425999002

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