Samsung Sleep Apnea Feature (Wear OS)

GUDID 08806094936872

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

Samsung Electronics Co., Ltd.

Patient general health self-management software

• Primary Device ID: 08806094936872
• NIH Device Record Key: 0f91996b-0308-4489-9e34-a5f7afbb8756
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Samsung Sleep Apnea Feature (Wear OS)
• Version Model Number: 1.X
• Company DUNS: 687967554
• Company Name: Samsung Electronics Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806094936872 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN230041

FDA Product Code

• QZW: Over-The-Counter Device To Assess Risk Of Sleep Apnea

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-04
• Device Publish Date: 2025-02-24

Devices Manufactured by Samsung Electronics Co., Ltd.

• 08806094936872 - Samsung Sleep Apnea Feature (Wear OS): 2025-03-04The 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
• 08806094936872 - Samsung Sleep Apnea Feature (Wear OS): 2025-03-04 The Sleep Apnea Feature is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung
• 08806094936889 - Samsung Sleep Apnea Feature (Android OS): 2025-03-04 The Sleep Apnea Feature is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung
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• 08806095799643 - NA: 2024-10-28 The GF85 Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trai
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