AccessGUDID - DEVICE: Samsung Sleep Apnea Feature (Wear OS) (08806094936872)

GUDID

Device Identifier (DI) Information

Brand Name: Samsung Sleep Apnea Feature (Wear OS)
Version or Model: 1.X
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Samsung Electronics Co., Ltd.

Primary DI Number: 08806094936872
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 687967554 *Terms of Use

Device Description: The Sleep Apnea Feature is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone. This feature is intended to detect signs of moderate to severe obstructive sleep apnea in the form of significant breathing disruptions in adult users 22 years and older, over a two-night monitoring period. This feature is intended for on-demand use. This feature is not intended for users who have previously been diagnosed with sleep apnea. Users should not use this feature to replace traditional methods of diagnosis and treatment by a qualified clinician. The data provided by this feature are also not intended to assist clinicians in diagnosing sleep disorders

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?
64275	Patient general health self-management software	An Internet-based software program intended to be used on a non-medical computerized device, by a patient in a non-clinical environment, to provide general health assessment information and/or health advice through an interactive platform; it is not dedicated to a specific condition. The software is intended to collect patient information (demographics, lifestyle data, and/or symptoms) and feedback information to indicate the general health/wellness in key areas (e.g., mental, cardiovascular) and/or assist the patient in deciding the best course of action if they are unwell (e.g., see a clinician, self-treatment for minor ailments). It does not communicate with a clinician.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QZW	Over-The-Counter Device To Assess Risk Of Sleep Apnea

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN230041	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: 0f91996b-0308-4489-9e34-a5f7afbb8756
Public Version Date: March 04, 2025
Public Version Number: 1
DI Record Publish Date: February 24, 2025