Catalog Number

-

Brand Name

N/A

Version/Model Number

30-02-013-1

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

K955461,K955461

Product Code

BTO

Product Code Name

Tube, Tracheostomy (W/Wo Connector)

Public Device Record Key

b455747f-a58e-4f2b-8b27-def7895226a5

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

May 13, 2016

Package DI Number

14250105605089

Quantity per Package

5

Contains DI Package

04250105605082

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-