Catalog Number

-

Brand Name

Drive

Version/Model Number

MQ3200

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

8744eef8-8471-4666-b5fe-d93f400897c8

Public Version Date

November 10, 2021

Public Version Number

3

DI Record Publish Date

September 16, 2016

Package DI Number

50822383579073

Quantity per Package

100

Contains DI Package

10822383579075

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-