Catalog Number

-

Brand Name

VIVE

Version/Model Number

DMD1047

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

17bdeb06-c1c7-40b7-ab7c-b4040acc1af7

Public Version Date

December 24, 2019

Public Version Number

1

DI Record Publish Date

December 16, 2019

Package DI Number

10810041980165

Quantity per Package

1

Contains DI Package

00810041980168

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case