AccessGUDID - DEVICE: Samsung ECG Monitor App with Irregular Heart Rhythm Notification (08806094940763)

GUDID

Device Identifier (DI) Information

Brand Name: Samsung ECG Monitor App with Irregular Heart Rhythm Notification
Version or Model: 1.X
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Samsung Electronics Co., Ltd.

Primary DI Number: 08806094940763
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 687967554 *Terms of Use

Device Description: The Samsung ECG Monitor Application with Irregular Heart Rhythm Notification is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone for informational use only in adults 22 years and older. The app analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of atrial fibrillation (AFib) and provides a notification suggesting the user record an ECG to analyze the heart rhythm. The Irregular Heart Rhythm Notification Feature is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the feature is intended to opportunistically acquire pulse rate data when the user is still and analyze the data when determined sufficient toward surfacing a notification.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58884	Self-care monitoring/reporting software	An application software program designed for the continual collection and aggregation of a patient's self-care data to promote communication between patient and healthcare provider, to facilitate a patient's self-care by using rules defined during use of the application, and/or to facilitate population monitoring. It is typically used to capture clinical (e.g., blood pressure, weight, and blood glucose), nutritional, and/or exercise information in the home, which may include medication administration information captured from enabled injection devices and data from wearable devices, providing care plan, journal, medication advice, and/or messaging functionalities.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QDA	Electrocardiograph Software For Over-The-Counter Use
QDB	Photoplethysmograph Analysis Software For Over-The-Counter Use

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K230292	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 79a20584-8685-457e-b26e-6d90dca27cf7
Public Version Date: July 15, 2024
Public Version Number: 2
DI Record Publish Date: October 23, 2023