AccuSom

GUDID 00860512000291

Home Sleep Test Kit v3

NOVASOM, INC.

Home-use sleep apnoea recording system

• Primary Device ID: 00860512000291
• NIH Device Record Key: 5bf348b9-2081-4a9e-8d17-2f5dedaab0d8
• Commercial Distribution Discontinuation: 2023-04-25
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: AccuSom
• Version Model Number: 1017-50003-US
• Company DUNS: 808379150
• Company Name: NOVASOM, 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: true
• 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

Customer Support Contacts

• Phone: (877) 753-3776
• Email: usinfo@bioserenity.com
• Phone: (877) 753-3776
• Email: usinfo@bioserenity.com
• Phone: (877) 753-3776
• Email: usinfo@bioserenity.com
• Phone: (877) 753-3776
• Email: usinfo@bioserenity.com
• Phone: (877) 753-3776
• Email: usinfo@bioserenity.com
• Phone: (877) 753-3776
• Email: usinfo@bioserenity.com
• Phone: (877) 753-3776
• Email: usinfo@bioserenity.com
• Phone: (877) 753-3776
• Email: usinfo@bioserenity.com
• Phone: (877) 753-3776
• Email: usinfo@bioserenity.com
• Phone: (877) 753-3776
• Email: usinfo@bioserenity.com
• Phone: (877) 753-3776
• Email: usinfo@bioserenity.com
• Phone: (877) 753-3776
• Email: usinfo@bioserenity.com
• Phone: (877) 753-3776
• Email: usinfo@bioserenity.com
• Phone: (877) 753-3776
• Email: usinfo@bioserenity.com
• Phone: (877) 753-3776
• Email: usinfo@bioserenity.com
• Phone: (877) 753-3776
• Email: usinfo@bioserenity.com
• Phone: (877) 753-3776
• Email: usinfo@bioserenity.com
• Phone: (877) 753-3776
• Email: usinfo@bioserenity.com
• Phone: (877) 753-3776
• Email: usinfo@bioserenity.com
• Phone: (877) 753-3776
• Email: usinfo@bioserenity.com
• Phone: (877) 753-3776
• Email: usinfo@bioserenity.com
• Phone: (877) 753-3776
• Email: usinfo@bioserenity.com
• Phone: (877) 753-3776
• Email: usinfo@bioserenity.com
• Phone: (877) 753-3776
• Email: usinfo@bioserenity.com
• Phone: (877) 753-3776
• Email: usinfo@bioserenity.com
• Phone: (877) 753-3776
• Email: usinfo@bioserenity.com
• Phone: (877) 753-3776
• Email: usinfo@bioserenity.com
• Phone: (877) 753-3776
• Email: usinfo@bioserenity.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860512000291 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-04-27
• Device Publish Date: 2023-01-13

On-Brand Devices [AccuSom]

• 00860512000208: Sleep apnea diagnosic device
• 00860512000246: Chain of Custody Disposable Sensors
• 00860512000239: Device box
• 00860512000222: Breath Sensor
• 00860512000215: Chain of Custody Patient Interface Dongle
• 00860512000253: Home Sleep Test Device v3
• 00860512000291: Home Sleep Test Kit v3
• 00860512000277: Breath Sensor v3
• 00860512000260: Chest Sensor v3