Catalog Number

-

Brand Name

Easy@Home Fingertip Pulse Oximeter

Version/Model Number

EHP035

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

K161560,K161560

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

296a22c6-a4e7-43e7-ae1c-cfaa09141182

Public Version Date

November 10, 2021

Public Version Number

2

DI Record Publish Date

February 03, 2020

Package DI Number

10810038630004

Quantity per Package

100

Contains DI Package

00810038630007

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton