Catalog Number

-

Brand Name

Finger pulse oximeter

Version/Model Number

FSA7649CM

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

-

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

14e645a0-bd9d-4b1b-9c1c-ce2bb80c5a84

Public Version Date

November 10, 2021

Public Version Number

2

DI Record Publish Date

March 08, 2021

Package DI Number

06944249302638

Quantity per Package

24

Contains DI Package

06944249302621

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-