Catalog Number

-

Brand Name

Vive

Version/Model Number

DMD1001SLV

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

5df6dd3b-00e3-446a-aa59-419e4777dbf9

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 11, 2016

Package DI Number

10861470000382

Quantity per Package

18

Contains DI Package

00861470000385

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case