CARDINAL HEALTH - Neuropath Specimen Replenishment Pack, Stanford - Aero-Med, Ltd.

Duns Number:194550042

Device Description: Neuropath Specimen Replenishment Pack, Stanford Medical Center Only

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More Product Details

Catalog Number

CA7226

Brand Name

CARDINAL HEALTH

Version/Model Number

CA7226

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 18, 2021

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

46b26cfe-0eab-4e67-ab5c-9dc0a42a36ec

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

January 04, 2019

Additional Identifiers

Package DI Number

50885380168794

Quantity per Package

25

Contains DI Package

10885380168796

Package Discontinue Date

February 18, 2021

Package Status

Not 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