Catalog Number

OCH

Brand Name

RENPHO Pulse Oximeter

Version/Model Number

RP-PO001

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

5b767b7f-166d-41b3-8fb9-c7796f7effad

Public Version Date

November 10, 2021

Public Version Number

2

DI Record Publish Date

September 15, 2020

Package DI Number

30850023727009

Quantity per Package

100

Contains DI Package

00850023727008

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton