Catalog Number

TVEB80110AS

Brand Name

VivaSight AS Pack Set include

Version/Model Number

TVEB80110AS

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

K120334,K152438,K120334,K152438

Product Code

BTR

Product Code Name

Tube, Tracheal (W/Wo Connector)

Public Device Record Key

4af48a73-41a5-4996-985b-6396a2e2aab4

Public Version Date

June 19, 2020

Public Version Number

4

DI Record Publish Date

February 21, 2018

Package DI Number

17290013745795

Quantity per Package

5

Contains DI Package

07290013745798

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton