Catalog Number

-

Brand Name

Irregular Rhythm Notifications

Version/Model Number

Feature Version 1.x

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

DEN180042

Product Code

QDB

Product Code Name

Photoplethysmograph Analysis Software For Over-The-Counter Use

Public Device Record Key

cf48daee-1326-4d28-b491-fbc97c2327ef

Public Version Date

July 08, 2020

Public Version Number

2

DI Record Publish Date

January 14, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-