Catalog Number

CA43775

Brand Name

Aero-Med

Version/Model Number

CA43775

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"

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

OIB

Product Code Name

Blood and urine collection kit (excludes HIV testing)

Public Device Record Key

726e1c41-a1a9-4e28-9b07-3d7d5ab7a4b5

Public Version Date

September 19, 2022

Public Version Number

1

DI Record Publish Date

September 09, 2022

Package DI Number

50885380193673

Quantity per Package

50

Contains DI Package

10885380193675

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE