Catalog Number

-

Brand Name

Vive Precision

Version/Model Number

DMD1063

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

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

4a005f98-ec34-44b0-afed-5d338314caee

Public Version Date

October 28, 2021

Public Version Number

1

DI Record Publish Date

October 20, 2021

Package DI Number

10810041987546

Quantity per Package

40

Contains DI Package

00810041987549

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case