Catalog Number

AMM5975

Brand Name

Aero-Med

Version/Model Number

AMM5975

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

KDT

Product Code Name

CONTAINER, SPECIMEN MAILER AND STORAGE, STERILE

Public Device Record Key

594239a6-a2e9-4c3b-8158-03a39aae6568

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

March 08, 2021

Package DI Number

50810010893098

Quantity per Package

1

Contains DI Package

00810010893093

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE