Accusom 1017-10001-US

GUDID 03615220004133

Sleep Apnea diagnostic Device

BIOSERENITY

Home-use sleep apnoea recording system

• Primary Device ID: 03615220004133
• NIH Device Record Key: 315d95e0-e3a3-484a-960e-e3def497ee3a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accusom
• Version Model Number: 1017-10001-US
• Catalog Number: 1017-10001-US
• Company DUNS: 265828238
• Company Name: BIOSERENITY
• 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: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860512000253 [Previous]
GS1	03615220004133 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110486

FDA Product Code

• MNR: Ventilatory Effort Recorder

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: 2023-05-04
• Device Publish Date: 2023-04-26

On-Brand Devices [Accusom]

• 03615220004157: Chest sensor
• 03615220004140: Breath sensor
• 03615220004133: Sleep Apnea diagnostic Device