CARDINAL HEALTH - SPECIMEN KIT, BONE MARROW, PATH CON - Aero-Med, Ltd.

Duns Number:194550042

Device Description: SPECIMEN KIT, BONE MARROW, PATH CON

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More Product Details

Catalog Number

CA1475

Brand Name

CARDINAL HEALTH

Version/Model Number

CA1475

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)

-

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

GAA

Product Code Name

NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Device Record Status

Public Device Record Key

2ee5ed9f-af21-41f6-b771-6d5e8e186342

Public Version Date

June 17, 2022

Public Version Number

3

DI Record Publish Date

April 12, 2019

Additional Identifiers

Package DI Number

50885380122055

Quantity per Package

5

Contains DI Package

10885380122057

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