CARDINAL HEALTH - DIALYSIS TRAY - Cardinal Health 200, LLC

Duns Number:961027315

Device Description: DIALYSIS TRAY

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More Product Details

Catalog Number

03-5329E

Brand Name

CARDINAL HEALTH

Version/Model Number

03-5329E

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

PEV

Product Code Name

Dialysis administration kit

Device Record Status

Public Device Record Key

a48984a2-e270-41d3-be67-4e57341b8e02

Public Version Date

October 06, 2022

Public Version Number

1

DI Record Publish Date

September 28, 2022

Additional Identifiers

Package DI Number

50195594834966

Quantity per Package

30

Contains DI Package

10195594834968

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