EnsoSleep

GUDID 00864458000407

Automated sleep scoring software.

ENSODATA, INC.

Sleep disorder interpretive software

• Primary Device ID: 00864458000407
• NIH Device Record Key: 7eac5f4c-f808-4474-8bd5-9b9dd4055e6d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EnsoSleep
• Version Model Number: 01.1
• 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: 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

Customer Support Contacts

• Phone: 6085094704
• Email: brock@ensodata.io

Device Identifiers

Device Issuing Agency	Device ID
GS1	00864458000407 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162627

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: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-12-11
• Device Publish Date: 2017-07-19

On-Brand Devices [EnsoSleep]

• 00864458000407: Automated sleep scoring software.
• 00864458000414: 7.0