CARDINAL HEALTH - FILTER SAMPLER 13MM - Cardinal Health 200, LLC

Duns Number:961027315

Device Description: FILTER SAMPLER 13MM

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More Product Details

Catalog Number

P5192-3

Brand Name

CARDINAL HEALTH

Version/Model Number

P5192-3

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"

-

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

JKA

Product Code Name

Tubes, vials, systems, serum separators, blood collection

Device Record Status

Public Device Record Key

2580a37c-b6df-4dd2-bc08-7c6716c1205b

Public Version Date

July 22, 2021

Public Version Number

6

DI Record Publish Date

August 15, 2016

Additional Identifiers

Package DI Number

50885380117556

Quantity per Package

40

Contains DI Package

30885380117552

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