Catalog Number

CA14850A

Brand Name

Aero-Med

Version/Model Number

CA14850A

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

7e5464ee-ba20-4948-9e94-c79b79cc5859

Public Version Date

February 26, 2021

Public Version Number

1

DI Record Publish Date

February 18, 2021

Package DI Number

50885380184398

Quantity per Package

25

Contains DI Package

10885380184390

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE