Catalog Number

-

Brand Name

MEDICAL ACTION INDUSTRIES

Version/Model Number

79619

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 07, 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

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

OGW

Product Code Name

Tracheostomy kit

Public Device Record Key

29e1fb33-9678-41f2-9474-47d68d2a6d58

Public Version Date

August 10, 2020

Public Version Number

2

DI Record Publish Date

July 17, 2019

Package DI Number

20809160246723

Quantity per Package

20

Contains DI Package

10809160246726

Package Discontinue Date

August 07, 2020

Package Status

Not in Commercial Distribution

Package Type

-