Catalog Number

CA36450

Brand Name

Aero-Med

Version/Model Number

CA36450

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

9bdb80b8-6797-4b19-bf2e-72411111c306

Public Version Date

April 08, 2022

Public Version Number

4

DI Record Publish Date

December 23, 2020

Package DI Number

50885380184022

Quantity per Package

50

Contains DI Package

10885380184024

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE