Catalog Number

-

Brand Name

Medical Action Industries

Version/Model Number

76333

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 22, 2019

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

NXA

Product Code Name

Tracheotomy care kit

Public Device Record Key

6ccc8dcc-841e-4e05-b6e8-1be8d1329bad

Public Version Date

October 21, 2020

Public Version Number

4

DI Record Publish Date

November 28, 2016

Package DI Number

20809160114916

Quantity per Package

20

Contains DI Package

10809160114919

Package Discontinue Date

January 22, 2019

Package Status

Not in Commercial Distribution

Package Type

-