Catalog Number

-

Brand Name

Carex

Version/Model Number

FGR41800 0000

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

-

Product Code

OCH

Product Code Name

Oximeter, Infrared, Sporting, Aviation

Public Device Record Key

72378ee2-6bc9-4a85-b98c-f39b65b330ee

Public Version Date

November 10, 2021

Public Version Number

2

DI Record Publish Date

June 05, 2019

Package DI Number

30023601064180

Quantity per Package

100

Contains DI Package

20023601064183

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-