DROWZLE Pro

GUDID 00860004872405

DROWZLE PRO is indicated to record a patient’s respiratory pattern during sleep for the purpose of prescreening patients for obstructive sleep apnea syndrome. The device is designed for use in home-screening of adults with suspected possible sleep breathing disorders. Results are used to assist the healthcare professional in determining the need for further diagnosis and evaluation. The system is not intended as a substitute for full polysomnography when additional parameters such as sleep stastages, limb movements, or EEG activity are required

RESONEA, INC.

Home-use sleep apnoea recording system

• Primary Device ID: 00860004872405
• NIH Device Record Key: 6f8533f0-9916-4f37-be75-9f04f293ba35
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DROWZLE Pro
• Version Model Number: 2.0
• Company DUNS: 079132539
• Company Name: RESONEA, 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860004872405 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-06-02
• Device Publish Date: 2020-11-04