Neurovirtual PV 2311
GUDID 00867975000288
BWMini PSG: Full-montage standard electroencephalograph device
M F Equipamentos Medicos Ltda Epp
Polysomnograph| Primary Device ID | 00867975000288 |
| NIH Device Record Key | 55a721c4-f2e7-4bc9-81a8-af5e1fd1c1da |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Neurovirtual |
| Version Model Number | BWMini PSG |
| Catalog Number | PV 2311 |
| Company DUNS | 904571309 |
| Company Name | M F Equipamentos Medicos Ltda Epp |
| 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 | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Operating and Storage Conditions
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 102 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 102 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 102 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 102 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 102 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 102 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 102 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 102 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 102 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 102 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 102 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 102 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 102 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 102 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 102 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 102 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 102 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 102 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 102 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 102 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 102 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 102 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 102 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 102 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 102 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 102 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 102 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 102 KiloPascal |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00867975000288 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K131335
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 | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-04-15 |
On-Brand Devices [Neurovirtual]
| 00867975000288 | BWMini PSG: Full-montage standard electroencephalograph device |
| 00867975000271 | BWMini HST: Full-montage standard electroencephalograph device |
| 00867975000264 | BWMini EEG: Full-montage standard electroencephalograph device |
| 00867975000257 | BWII PSG Digital: Full-montage standard electroencephalograph device |
| 00867975000240 | BWII EEG Digital: Full-montage standard electroencephalograph device |
| 00867975000233 | BWIII EEG: Full-montage standard electroencephalograph device |
| 00867975000226 | BWIII PSG: Full-montage standard electroencephalograph device |
| 00867975000219 | BWIII EEG Plus: Full-montage standard electroencephalograph device |
| 00867975000202 | BWIII PSG Plus: Full-montage standard electroencephalograph device |
Trademark Results [Neurovirtual]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NEUROVIRTUAL 78922440 not registered Dead/Abandoned |
Neurovirtual USA, Inc. 2006-07-05 |
 NEUROVIRTUAL 77204897 3378310 Live/Registered |
Neurovirtual USA, Inc. 2007-06-13 |
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