Catalog Number

-

Brand Name

VIVE

Version/Model Number

DMD1030

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

DPS

Product Code Name

Electrocardiograph

Public Device Record Key

ad9ce751-13f2-4618-8324-f7636b139167

Public Version Date

November 01, 2019

Public Version Number

1

DI Record Publish Date

October 24, 2019

Package DI Number

10818323029786

Quantity per Package

150

Contains DI Package

00818323029789

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case