CARDINAL HEALTH - Trumpet Valve w/ Single Spike and no Probe - Cardinal Health 200, LLC

Duns Number:961027315

Device Description: Trumpet Valve w/ Single Spike and no Probe

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More Product Details

Catalog Number

ASC1220

Brand Name

CARDINAL HEALTH

Version/Model Number

ASC1220

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 12, 2021

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

GBX

Product Code Name

CATHETER, IRRIGATION

Device Record Status

Public Device Record Key

b42aa82f-f069-46eb-b120-467c96e789de

Public Version Date

August 13, 2021

Public Version Number

6

DI Record Publish Date

July 22, 2016

Additional Identifiers

Package DI Number

50885380107847

Quantity per Package

12

Contains DI Package

10885380107849

Package Discontinue Date

August 12, 2021

Package Status

Not 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