Catalog Number

-

Brand Name

Vive

Version/Model Number

DMD1009

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

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

a5812944-28bc-4e38-b3e3-039ef2ff7e0b

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 08, 2016

Package DI Number

20861470000365

Quantity per Package

10

Contains DI Package

00861470000361

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Pack