CARDINAL HEALTH - TUBE 15ML CAP PLUG PP 50 CAP RCK S/ - Cardinal Health 200, LLC

Duns Number:961027315

Device Description: TUBE 15ML CAP PLUG PP 50 CAP RCK S/

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More Product Details

Catalog Number

SP3920-80

Brand Name

CARDINAL HEALTH

Version/Model Number

SP3920-80

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)

-

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

FMH

Product Code Name

CONTAINER, SPECIMEN, STERILE

Device Record Status

Public Device Record Key

147d7060-03d2-4397-9627-029917c706f5

Public Version Date

December 27, 2021

Public Version Number

2

DI Record Publish Date

April 11, 2019

Additional Identifiers

Package DI Number

50885380012592

Quantity per Package

10

Contains DI Package

20885380012591

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