Catalog Number

380

Brand Name

EcoVue HV

Version/Model Number

380

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

-

Product Code

MUI

Product Code Name

Media, coupling, ultrasound

Public Device Record Key

00038e6f-f4d8-4ecc-9431-764db08254e9

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

September 21, 2020

Package DI Number

30851809002020

Quantity per Package

6

Contains DI Package

10851809002026

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case