Catalog Number

-

Brand Name

Medical Action Industries

Version/Model Number

56791C

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

NXA

Product Code Name

Tracheotomy care kit

Public Device Record Key

53da2a6f-2651-41dc-9369-e89f85c09a1e

Public Version Date

October 21, 2020

Public Version Number

2

DI Record Publish Date

August 13, 2020

Package DI Number

20809160289829

Quantity per Package

20

Contains DI Package

10809160289822

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-