Catalog Number

TVT80110

Brand Name

VivaSight-SL

Version/Model Number

TVT80110

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

K152438,K152438,K152438

Product Code

BTR

Product Code Name

Tube, Tracheal (W/Wo Connector)

Public Device Record Key

bcddebdc-e59f-4c84-89d2-80a0c04735fe

Public Version Date

June 19, 2020

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

17290013745023

Quantity per Package

10

Contains DI Package

07290013745026

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton