Catalog Number

-

Brand Name

Easy@Home Fingertip Pulse Oximeter

Version/Model Number

EHP50D1

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

OCH

Product Code Name

Oximeter, Infrared, Sporting, Aviation

Public Device Record Key

2261b8f1-d4bb-4868-8d6a-798be75437fe

Public Version Date

November 10, 2021

Public Version Number

2

DI Record Publish Date

June 14, 2019

Package DI Number

10850003180196

Quantity per Package

200

Contains DI Package

00850003180199

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton