Catalog Number

H2O-020

Brand Name

envision Transducer Cover

Version/Model Number

H2O-020

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

Yes

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

K190802,K190802

Product Code

ITX

Product Code Name

Transducer, ultrasonic, diagnostic

Public Device Record Key

184daee5-e843-4f0d-bc13-24caaf5d72f9

Public Version Date

November 29, 2021

Public Version Number

1

DI Record Publish Date

November 20, 2021

Package DI Number

00841436122023

Quantity per Package

24

Contains DI Package

10841436122020

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-