Catalog Number

-

Brand Name

Drive

Version/Model Number

MQ3000

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)

Yes

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

OCH

Product Code Name

Oximeter, Infrared, Sporting, Aviation

Public Device Record Key

e3bf4048-49f0-4998-bd99-c46c07386005

Public Version Date

November 10, 2021

Public Version Number

6

DI Record Publish Date

September 16, 2016

Package DI Number

50822383579066

Quantity per Package

100

Contains DI Package

10822383579068

Package Discontinue Date

April 24, 2020

Package Status

Not in Commercial Distribution

Package Type

-