Catalog Number

CA23825

Brand Name

Aero-Med

Version/Model Number

CA23825

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

OIB

Product Code Name

Blood and urine collection kit (excludes HIV testing)

Public Device Record Key

c4a19def-04e1-4a22-8faa-45ec4a312ef1

Public Version Date

October 23, 2019

Public Version Number

2

DI Record Publish Date

July 24, 2019

Package DI Number

50885380174207

Quantity per Package

50

Contains DI Package

10885380174209

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE