Catalog Number

-

Brand Name

Medical Action Industries

Version/Model Number

8201

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 17, 2018

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

CBH

Product Code Name

DEVICE, FIXATION, TRACHEAL TUBE

Public Device Record Key

21741b20-7e03-4ff5-b069-adffea93a707

Public Version Date

June 05, 2020

Public Version Number

4

DI Record Publish Date

August 20, 2016

Package DI Number

30809160023789

Quantity per Package

4

Contains DI Package

20809160023782

Package Discontinue Date

December 17, 2018

Package Status

Not in Commercial Distribution

Package Type

-