Catalog Number

-

Brand Name

VX3+

Version/Model Number

VX3+ Series H

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

MWJ

Product Code Name

Electrocardiograph,Ambulatory(Without Analysis)

Public Device Record Key

5cf17aec-56e1-4180-a269-cc0647c0f42a

Public Version Date

November 08, 2019

Public Version Number

3

DI Record Publish Date

November 02, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-