Catalog Number

RES5100

Brand Name

Sunset Fingertip Pulse Oximeter

Version/Model Number

RES5100

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

7974560f-6196-41db-bb5e-ec4d1dd8c4ff

Public Version Date

November 10, 2021

Public Version Number

2

DI Record Publish Date

September 19, 2018

Package DI Number

10848530061163

Quantity per Package

300

Contains DI Package

00848530061166

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-