CARDINAL HEALTH - Chemical Integrator Pack - Cardinal Health 200, LLC

Duns Number:961027315

Device Description: Chemical Integrator Pack

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More Product Details

Catalog Number

T40340

Brand Name

CARDINAL HEALTH

Version/Model Number

T40340

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

January 01, 2025

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

JOJ

Product Code Name

Indicator, physical/chemical sterilization process

Device Record Status

Public Device Record Key

0b3618f9-dc09-4462-9d2c-3fc84485de96

Public Version Date

February 19, 2021

Public Version Number

5

DI Record Publish Date

October 04, 2016

Additional Identifiers

Package DI Number

50885380031050

Quantity per Package

4

Contains DI Package

20885380031059

Package Discontinue Date

January 01, 2025

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