DEVICE: Compumedics Grael (09342451001276)
Device Identifier (DI) Information
Compumedics Grael
Grael
In Commercial Distribution
9028-0001-02
COMPUMEDICS LIMITED
Grael
In Commercial Distribution
9028-0001-02
COMPUMEDICS LIMITED
Grael v2 System, no software
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| No | |
| Yes | |
| No | |
| Yes | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 11467 | Electroencephalograph |
An electrically-powered device designed for noninvasive recording of the electrical activity of the brain for display in the form of a graph [electroencephalogram (EEG)], typically to study a variety of neurological conditions, evaluate psychiatric disorders, and/or assist in localizing tumours or lesions on or near the surface of the brain. It is designed to acquire electrical signals from electrodes typically attached to the scalp and ear lobes. The results may be displayed via print-out or electronically; data interpretation and/or telemetry features may also be included.
|
Active | false |
| 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.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| GWQ | Full-Montage Standard Electroencephalograph |
| OLV | Standard Polysomnograph With Electroencephalograph |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K093223 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Handling Environment Humidity: between 20 and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature: between -10 and 50 Degrees Celsius |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
d00f464e-2fed-4108-90ab-ef8d2e8f5094
November 28, 2022
5
November 29, 2016
November 28, 2022
5
November 29, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| No Package DIs found | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+61384207386
support@compumedics.com.au 1-877-294-1346
support@compumedicsusa.com
support@compumedics.com.au 1-877-294-1346
support@compumedicsusa.com