Cardinal Health - CARDINAL HEALTH® UA CONTROL DROPPER BOTTLE SET, - KOVA INTERNATIONAL, INC.

Duns Number:078780990

Device Description: CARDINAL HEALTH® UA CONTROL DROPPER BOTTLE SET, 5mL

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More Product Details

Catalog Number

89211

Brand Name

Cardinal Health

Version/Model Number

89211

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

JJW

Product Code Name

Urinalysis Controls (Assayed And Unassayed)

Device Record Status

Public Device Record Key

9fd58dd0-8c08-40af-9e15-1324888a2511

Public Version Date

September 11, 2020

Public Version Number

1

DI Record Publish Date

September 03, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KOVA INTERNATIONAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 114