Sleep Apnea Notification Feature (SANF)

GUDID 00195949116193

Sleep Apnea Notification Feature WatchOS (version 1.X)

APPLE INC.

Self-care monitoring/reporting software

• Primary Device ID: 00195949116193
• NIH Device Record Key: 9035b761-79de-4905-a61d-aeb4e5835032
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sleep Apnea Notification Feature (SANF)
• Version Model Number: Feature version 1.X
• Company DUNS: 060704780
• Company Name: APPLE INC.
• 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: true
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00195949116193 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240929

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: 2024-09-26
• Device Publish Date: 2024-09-18

On-Brand Devices [Sleep Apnea Notification Feature (SANF)]

• 00195949116209: Sleep Apnea Notification Feature iOS (version 1.X)
• 00195949116193: Sleep Apnea Notification Feature WatchOS (version 1.X)