Compumedics Somte

Basic Information

• Brand Name: Compumedics Somte
• Primary DI: 09342451001733
• Version / Model: Somte
• Catalog Number: 9012-0003-01
• Company Name: COMPUMEDICS LIMITED
• Labeler DUNS: 753750967
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-11-17
• Public Version: 4
• Public Version Date: 2021-04-27
• Public Version Status: Update
• Public Device Record Key: e19be9b3-1887-41a6-9e04-d1ad05f214ca

Device Description

Somte Recording System Compumedics, no Software

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• Has Lot/Batch Number: No
• 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
33843	Polysomnograph	A mains electricity (AC-powered) device designed to record physiological signals from a sleeping patient to assess sleep disorders (e.g., insomnia, snoring or sleep apnoea). The device is typically computerized and usually records an electrocardiogram (ECG), electroencephalogram (EEG), chest wall motion, airflow at both the nose and the mouth, eye movements, haemoglobin oxygen saturation (SpO2) and electromyogram (EMG). Parameters may be added or omitted depending on the study being performed. The device includes multiple electrodes/sensors placed on the patient in specific areas as well as amplifiers and filters for recording.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09342451001733	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K021176	000

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 30 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -20 – 50 Degrees Celsius