Celeste+

GUDID 00864458000452

Mobile app for recording breath sounds and snoring during sleep, along with file transfer from Bluetooth sleep recording devices

ENSODATA, INC.

Sleep disorder interpretive software, professional-only

• Primary Device ID: 00864458000452
• NIH Device Record Key: adbd92f4-4c05-4213-a28b-ee673217a12c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Celeste+
• 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	00864458000452 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173974

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: 2025-04-15
• Device Publish Date: 2025-04-07

Devices Manufactured by ENSODATA, INC.

• 00864458000469 - EnsoSleep PPG: 2025-04-22 Sleep quality and sleep disordered breathing detection from pulse oximeters. Marketed as EnsoSleep PPG or Aurora
• 00864458000476 - EnsoSleep: 2025-04-22 Automated sleep study scoring and report generation by EnsoData
• 00864458000445 - EnsoSleep PPG: 2025-04-15 Sleep quality and sleep disordered breathing detection from pulse oximeters. Marketed as EnsoSleep PPG or Aurora
• 00864458000452 - Celeste+: 2025-04-15Mobile app for recording breath sounds and snoring during sleep, along with file transfer from Bluetooth sleep recording devices
• 00864458000452 - Celeste+: 2025-04-15 Mobile app for recording breath sounds and snoring during sleep, along with file transfer from Bluetooth sleep recording devices
• 00864458000414 - EnsoSleep: 2024-03-04
• 00864458000421 - EnsoTherapy: 2023-11-28 EnsoTherapy is a clinical decision support (CDS)/Medical Device Data System (MDDS) non-medical device product that allows clinic
• 00864458000407 - EnsoSleep: 2019-12-11 Automated sleep scoring software.