Catalog Number

-

Brand Name

Vive

Version/Model Number

DMD1003BLK

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

OCH

Product Code Name

Oximeter, Infrared, Sporting, Aviation

Public Device Record Key

e899244d-23c4-4824-aed6-6c0cf2501130

Public Version Date

November 10, 2021

Public Version Number

3

DI Record Publish Date

August 05, 2016

Package DI Number

10861470000306

Quantity per Package

2

Contains DI Package

00861470000309

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Pack