Catalog Number

QUE2550

Brand Name

Aero-Med

Version/Model Number

QUE2550

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

04f00bdf-f324-41fd-9526-582a6babb45d

Public Version Date

January 13, 2021

Public Version Number

1

DI Record Publish Date

January 05, 2021

Package DI Number

50810010893036

Quantity per Package

10

Contains DI Package

00810010893031

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE