Catalog Number

TVEB80110

Brand Name

VivaSight Pack

Version/Model Number

TVEB80110

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

-

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

K120334,K152438,K120334,K152438

Product Code

BTR

Product Code Name

Tube, Tracheal (W/Wo Connector)

Public Device Record Key

473b0078-458d-4bf4-9655-7fc0ed2900e2

Public Version Date

June 19, 2020

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

17290013745566

Quantity per Package

5

Contains DI Package

07290013745569

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton