EnsoSleep PPG

GUDID 00864458000469

Sleep quality and sleep disordered breathing detection from pulse oximeters. Marketed as EnsoSleep PPG or Aurora

ENSODATA, INC.

Sleep disorder interpretive software, professional-only

• Primary Device ID: 00864458000469
• NIH Device Record Key: 3f528f5e-2bfb-4599-8f90-5af6ace3da19
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EnsoSleep PPG
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00864458000469 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231355

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

On-Brand Devices [EnsoSleep PPG]

• 00864458000445: Sleep quality and sleep disordered breathing detection from pulse oximeters. Marketed as EnsoSl
• 00864458000469: Sleep quality and sleep disordered breathing detection from pulse oximeters. Marketed as EnsoSl