Catalog Number

JPD-500F

Brand Name

Qardio Pulse Oximeter

Version/Model Number

JPD-500F

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

K170965,K170965

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

69c56417-b46b-4bee-b456-ee86b8b9671a

Public Version Date

November 10, 2021

Public Version Number

2

DI Record Publish Date

January 13, 2021

Package DI Number

10854894005415

Quantity per Package

100

Contains DI Package

00854894005418

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-