Catalog Number

-

Brand Name

HOMEDICS

Version/Model Number

PX-131CO

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

6fbd667a-56e1-4e49-aeea-22bd43413791

Public Version Date

November 10, 2021

Public Version Number

3

DI Record Publish Date

July 03, 2020

Package DI Number

10031262100020

Quantity per Package

6

Contains DI Package

00031262100023

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case