CARDINAL HEALTH - FRZ PLASMA 50 cf 120v 60hz - Cardinal Health 200, LLC

Duns Number:961027315

Device Description: FRZ PLASMA 50 cf 120v 60hz

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More Product Details

Catalog Number

CAX5030LA

Brand Name

CARDINAL HEALTH

Version/Model Number

CAX5030LA

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

-

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

JRM

Product Code Name

FREEZER

Device Record Status

Public Device Record Key

dc1a6b5c-1a3d-42b4-b918-e1c2df0b8262

Public Version Date

June 17, 2022

Public Version Number

2

DI Record Publish Date

March 18, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"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