Catalog Number

CA36825

Brand Name

Aero-Med

Version/Model Number

CA36825

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

NNK

Product Code Name

CONTAINER, SPECIMEN MAILER AND STORAGE, NON-STERILE

Public Device Record Key

bfc7e3ca-194e-4fd1-9b0f-41b144ed4230

Public Version Date

March 16, 2021

Public Version Number

1

DI Record Publish Date

March 08, 2021

Package DI Number

50885380184411

Quantity per Package

4

Contains DI Package

10885380184413

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE