Catalog Number

286

Brand Name

EcoVue

Version/Model Number

286

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

-

Product Code

MUI

Product Code Name

Media, coupling, ultrasound

Public Device Record Key

1de2fa79-0ccf-44b1-af0e-d5a7f0406437

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

February 12, 2019

Package DI Number

10851809002866

Quantity per Package

12

Contains DI Package

00851809002869

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box