Catalog Number

-

Brand Name

Vivid

Version/Model Number

S v203 v204 v205 to v206 UPG

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K220619

Product Code

ITX

Product Code Name

Transducer, ultrasonic, diagnostic

Public Device Record Key

f08f802a-e59b-4826-bdd8-0bce217841f8

Public Version Date

August 22, 2022

Public Version Number

1

DI Record Publish Date

August 12, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-