Catalog Number

-

Brand Name

Medical Action Industries

Version/Model Number

79509

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 27, 2020

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

NXA

Product Code Name

Tracheotomy care kit

Public Device Record Key

43cc3fa0-d1d0-40bf-aa6d-a684c0717597

Public Version Date

October 21, 2020

Public Version Number

3

DI Record Publish Date

August 19, 2019

Package DI Number

20809160253967

Quantity per Package

24

Contains DI Package

10809160253960

Package Discontinue Date

July 27, 2020

Package Status

Not in Commercial Distribution

Package Type

-