Catalog Number

-

Brand Name

Vive Precision

Version/Model Number

DMD1034WHT

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

K170965,K170965

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

002d7e11-50fc-4263-a81b-8d6ea77abffb

Public Version Date

November 10, 2021

Public Version Number

4

DI Record Publish Date

February 01, 2018

Package DI Number

10818323022091

Quantity per Package

100

Contains DI Package

00818323022094

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case