Catalog Number

C-CAE-14.0-83-01

Brand Name

Cook

Version/Model Number

G57622

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"

-

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

BTR

Product Code Name

Tube, tracheal (w/wo connector)

Public Device Record Key

365ee11b-ecd1-4155-b168-f491f2beddbb

Public Version Date

April 06, 2020

Public Version Number

1

DI Record Publish Date

March 27, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-