Catalog Number

-

Brand Name

RENPHO Pulse Oximeter

Version/Model Number

R-J002

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

K173123,K173123

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

faa79af9-a6a9-4923-bb80-925298d9f892

Public Version Date

November 10, 2021

Public Version Number

2

DI Record Publish Date

May 24, 2020

Package DI Number

50860002249655

Quantity per Package

200

Contains DI Package

00860002249650

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton