CARDINAL HEALTH - 23 cu.ft. Premier Plus -30 Plasma Freezer 208-220v - Cardinal Health 200, LLC

Duns Number:961027315

Device Description: 23 cu.ft. Premier Plus -30 Plasma Freezer 208-220v

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More Product Details

Catalog Number

CAX2330LD

Brand Name

CARDINAL HEALTH

Version/Model Number

CAX2330LD

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

KSE

Product Code Name

REFRIGERATOR, FREEZER, BLOOD STORAGE

Device Record Status

Public Device Record Key

ee38176b-ff6d-43b4-ac8f-3352b6ee0964

Public Version Date

November 04, 2021

Public Version Number

1

DI Record Publish Date

October 27, 2021

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