Catalog Number

450015

Brand Name

Hebeler Safe-T-Tube™

Version/Model Number

450015

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 15, 2016

Issuing Agency

In HIBCC

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

BTR

Product Code Name

Tube, Tracheal (W/Wo Connector)

Public Device Record Key

96e3d7db-37ae-4b37-abde-4da3c94c4d99

Public Version Date

August 30, 2022

Public Version Number

3

DI Record Publish Date

September 20, 2015

Package DI Number

EBES4500151

Quantity per Package

1

Contains DI Package

EBES4500150

Package Discontinue Date

April 15, 2016

Package Status

Not in Commercial Distribution

Package Type

Carton