Catalog Number

-

Brand Name

Vive Precision

Version/Model Number

DMD1001BLK

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

86a550de-9831-4b85-909b-c9fbcfcbdc7f

Public Version Date

March 11, 2019

Public Version Number

1

DI Record Publish Date

February 25, 2019

Package DI Number

10818323026624

Quantity per Package

18

Contains DI Package

00818323026627

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-