Catalog Number

-

Brand Name

Areta Fingertip Pulse Oximeter

Version/Model Number

EZD-500A

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

K140582,K140582

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

87518235-cf96-4483-89de-1125893c95b1

Public Version Date

November 26, 2018

Public Version Number

4

DI Record Publish Date

August 01, 2016

Package DI Number

10850253007106

Quantity per Package

100

Contains DI Package

00850253007109

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-