Catalog Number

CA44575

Brand Name

Aero-Med

Version/Model Number

CA44575

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)

Yes

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

e635e4eb-f790-40e8-bbb0-e7edc94b8d7a

Public Version Date

August 02, 2022

Public Version Number

1

DI Record Publish Date

July 25, 2022

Package DI Number

50885380193482

Quantity per Package

50

Contains DI Package

10885380193484

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE