Catalog Number

EBB09700AS

Brand Name

VivaSight-EB

Version/Model Number

EBB09700AS

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"

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,K120334

Product Code

CBI

Product Code Name

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

Public Device Record Key

c801d22d-66bb-4a26-8362-8e59b2e72898

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 21, 2018

Package DI Number

17290013745801

Quantity per Package

5

Contains DI Package

07290013745804

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton