Catalog Number

-

Brand Name

Pulse Oximeter

Version/Model Number

MP-OX300

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K140582,K140582,K140582

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

b80aa21c-27fd-4a70-8456-bc7687e42cdd

Public Version Date

November 10, 2021

Public Version Number

5

DI Record Publish Date

September 15, 2017

Package DI Number

00817746021233

Quantity per Package

100

Contains DI Package

00817746028874

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-