Catalog Number

TVT80110AS

Brand Name

TRACHEOSCOPIC VENTILATION TUBE AS

Version/Model Number

TVT80110AS

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

-

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

K152438,K152438,K152438

Product Code

BTR

Product Code Name

Tube, Tracheal (W/Wo Connector)

Public Device Record Key

b6d1bb42-7f80-44e5-ab17-9cd370cc5186

Public Version Date

June 19, 2020

Public Version Number

4

DI Record Publish Date

February 21, 2018

Package DI Number

27290013745761

Quantity per Package

10

Contains DI Package

17290013745764

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton