Catalog Number

-

Brand Name

Medical Action Industries

Version/Model Number

78005B

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)

Yes

Over the Counter (OTC)

-

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

43ef6c2f-e8fa-4704-be11-3b667fdf83fe

Public Version Date

July 22, 2021

Public Version Number

3

DI Record Publish Date

February 10, 2021

Package DI Number

20809160345297

Quantity per Package

20

Contains DI Package

10809160345290

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-