Catalog Number

-

Brand Name

VIVE

Version/Model Number

DMD1041

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

MNW

Product Code Name

Analyzer, Body Composition

Public Device Record Key

16d3f48a-e3bc-45dc-8116-5101b3948d03

Public Version Date

November 28, 2019

Public Version Number

1

DI Record Publish Date

November 20, 2019

Package DI Number

10818323029946

Quantity per Package

6

Contains DI Package

00818323029949

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case