Catalog Number

-

Brand Name

n.a.

Version/Model Number

35-40-633

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

CBH

Product Code Name

Device, Fixation, Tracheal Tube

Public Device Record Key

b5621587-20e4-44dd-bdfe-b1370c1f9e13

Public Version Date

September 28, 2020

Public Version Number

1

DI Record Publish Date

September 18, 2020

Package DI Number

14250105601197

Quantity per Package

10

Contains DI Package

04250105601190

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-