Compumedics 8022-0063-01
GUDID 09342451001856
Photic Stimulator
COMPUMEDICS LIMITED
Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph| Primary Device ID | 09342451001856 |
| NIH Device Record Key | 7a343831-fdba-4ae2-8130-360dfad6ef0b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Compumedics |
| Version Model Number | 8022-0063-01 |
| Catalog Number | 8022-0063-01 |
| Company DUNS | 753750967 |
| Company Name | COMPUMEDICS LIMITED |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | true |
| 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 |
Customer Support Contacts
Operating and Storage Conditions
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 09342451001856 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K093223
FDA Product Code
| GWQ | Full-Montage Standard Electroencephalograph |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2021-04-27 |
| Device Publish Date | 2016-12-22 |
On-Brand Devices [Compumedics]
| 09342451001863 | Assembly - Grael Trolley |
| 09342451001856 | Photic Stimulator |
| 09342451001849 | Grael event button V2_Green |
| 09342451001467 | Adult silicone soft tip finger probe-oximeter-1m |
Trademark Results [Compumedics]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 COMPUMEDICS 75294981 2482641 Live/Registered |
COMPUMEDICS LIMITED 1997-05-20 |
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