EnsoSleep

GUDID 00864458000476

Automated sleep study scoring and report generation by EnsoData

ENSODATA, INC.

Sleep disorder interpretive software, professional-only

• Primary Device ID: 00864458000476
• NIH Device Record Key: 66acc31b-b78d-4699-a7a9-0d132f175c9c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EnsoSleep
• Version Model Number: 8.0
• Company DUNS: 080743964
• Company Name: ENSODATA, 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: 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	00864458000476 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210034

FDA Product Code

• OLZ: Automatic Event Detection Software For Polysomnograph With Electroencephalograph

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: 2025-04-22
• Device Publish Date: 2025-04-14

On-Brand Devices [EnsoSleep]

• 00864458000407: Automated sleep scoring software.
• 00864458000414: 7.0
• 00864458000476: Automated sleep study scoring and report generation by EnsoData