MICHELE SLEEP SCORING SYSTEM

Basic Information

• Brand Name: MICHELE SLEEP SCORING SYSTEM
• Primary DI: B6005537160
• Version / Model: 1
• Company Name: Cerebra Medical Ltd
• Labeler DUNS: 203513726
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-02-12
• Public Version: 7
• Public Version Date: 2022-10-24
• Public Version Status: Update
• Public Device Record Key: 9670deea-4578-4e2c-9ccc-0064d249cd14

Device Description

The MICHELE Sleep Scoring System is a Computer program (software) intended for use as an aid for the diagnosis of sleep and respiratory related sleep disorders. The MICHELE Sleep Scoring System is intended to be used for analysis (automatic scoring and manual rescoring), display, redisplay (retrieve), summarize, reports generation and networking of digital data collected by monitoring devices typically used to evaluate sleep and respiratory related sleep disorders. The device is to be used under the supervision of a physician. Use is restricted to files obtained from adult patients.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MNR	Ventilatory Effort Recorder	Anesthesiology	868.2375	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64938	Sleep disorder interpretive software, professional-only	An interpretive software program intended to be used exclusively by healthcare professionals to collect and analyse patient physiological data during sleep and publish reports to assist diagnosis of sleep disorders (e.g., insomnia, sleep apnoea). It is typically used as part of a polysomnography study using a wide range of data of [e.g., electrocardiogram (ECG), electroencephalogram (EEG), haemoglobin oxygen saturation (SpO2), chest wall motion, airflow, eye movement].	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B6005537160	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K112102	000