Catalog Number

H2O-006, H2O-006-5

Brand Name

envision Ultrasound Pad

Version/Model Number

H2O-006, H2O-006-5

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

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,K190802

Product Code

ITX

Product Code Name

Transducer, ultrasonic, diagnostic

Public Device Record Key

e7082f7b-c68b-440b-805e-2a9ec35111b4

Public Version Date

September 06, 2021

Public Version Number

2

DI Record Publish Date

June 19, 2019

Package DI Number

00841436114950

Quantity per Package

5

Contains DI Package

10841436114940

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-