Catalog Number

-

Brand Name

Easy@home

Version/Model Number

EHP029

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

05bcc1db-985b-4453-9d47-51732c1b0ebf

Public Version Date

November 10, 2021

Public Version Number

2

DI Record Publish Date

May 25, 2020

Package DI Number

16942820462075

Quantity per Package

100

Contains DI Package

06942820462078

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-