Catalog Number

EBB09700

Brand Name

VivaSight-EB

Version/Model Number

EBB09700

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,K120334

Product Code

CBI

Product Code Name

Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)

Public Device Record Key

db715a41-f976-48f0-a65d-81434a966895

Public Version Date

August 15, 2018

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

17290013745511

Quantity per Package

5

Contains DI Package

07290013745514

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton