CARDINAL HEALTH - Blood Collection Kit, IU Healthy Results, IU - Aero-Med, Ltd.

Duns Number:194550042

Device Description: Blood Collection Kit, IU Healthy Results, IU Health Only

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More Product Details

Catalog Number

CA19875

Brand Name

CARDINAL HEALTH

Version/Model Number

CA19875

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

OIB

Product Code Name

Blood and urine collection kit (excludes HIV testing)

Device Record Status

Public Device Record Key

6a42565f-e5fd-48dd-8efd-a1d2d09dd034

Public Version Date

February 11, 2019

Public Version Number

1

DI Record Publish Date

January 10, 2019

Additional Identifiers

Package DI Number

50885380168763

Quantity per Package

50

Contains DI Package

10885380168765

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"AERO-MED, LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 467
2 A medical device with a moderate to high risk that requires special controls. 14