Catalog Number

-

Brand Name

McKesson

Version/Model Number

MCKFOL

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)

-

Over the Counter (OTC)

-

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

72a8529e-c9cf-437c-9ed2-fa3396e27e14

Public Version Date

December 04, 2020

Public Version Number

4

DI Record Publish Date

September 20, 2018

Package DI Number

00612479229334

Quantity per Package

10

Contains DI Package

00612479228719

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case