Neurovirtual PV2311
GUDID 00850008393228
Polysomnograph BWMini PSG
NEUROVIRTUAL USA, INC.
Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph| Primary Device ID | 00850008393228 |
| NIH Device Record Key | dbf47d8e-a393-4fe1-a7f7-744a8026514f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Neurovirtual |
| Version Model Number | BWMini PSG |
| Catalog Number | PV2311 |
| Company DUNS | 791140622 |
| Company Name | NEUROVIRTUAL USA, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| 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 | true |
| OTC Over-The-Counter | false |
Operating and Storage Conditions
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 102 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 102 KiloPascal |
| 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 Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 102 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 102 KiloPascal |
| 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 Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 102 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 102 KiloPascal |
| 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 Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 102 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 102 KiloPascal |
| 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 Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 102 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 102 KiloPascal |
| 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 Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 102 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 102 KiloPascal |
| 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 Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 102 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 102 KiloPascal |
| 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 Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 102 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 102 KiloPascal |
| 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 Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 102 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 102 KiloPascal |
| 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 Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 102 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 102 KiloPascal |
| 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 Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 102 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 102 KiloPascal |
| 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 Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 102 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 102 KiloPascal |
| 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 Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 102 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 102 KiloPascal |
| 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 Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 102 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 102 KiloPascal |
| 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 Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 102 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 102 KiloPascal |
| 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 Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 102 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 102 KiloPascal |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850008393228 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K112107
FDA Product Code
| OLV | Standard Polysomnograph With Electroencephalograph |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-12-04 |
| Device Publish Date | 2019-11-26 |
On-Brand Devices [Neurovirtual]
| 00850008393280 | The Maxxi Snore Sensor is a device intended to acquire snore bursts |
| 00850008393273 | The Maxxi Snore Sensor is a device intended to acquire snore bursts |
| 00850008393266 | piezo-electric element covered by Thermoplastic elastomers 2 ft lenght |
| 00850008393259 | Polysomnograph BWMini HST Compass |
| 00850008393242 | Polysomnograph BWMini HST |
| 00850008393235 | Electroencephalograph BWMini EEG |
| 00850008393228 | Polysomnograph BWMini PSG |
| 00850008393211 | Polysomnograph and Electroencephalograph BWIII PSG Plus |
| 00850008393204 | Polysomnograph BWIII PSG |
| 00850008393198 | Electroencephalograph BWIII EEG Plus |
| 00850008393181 | Electroencephalograph BWIII EEG |
| 00850008393174 | Electroencephalograph BWIII Basics |
| 00850008393167 | Maxxi Rip System length: .3ft is a device intended to capture respiratory effort from a patient |
| 00850008393150 | Maxxi Rip System length: 7ft is a device intended to capture respiratory effort from a patient a |
| 00850008393143 | Maxxi Rip Abdomen Interface 7ft is a device intended to capture respiratory effort from a patien |
| 00850008393136 | Maxxi Rip Abdomen Interface 3ft is a device intended to capture respiratory effort from a patien |
| 00850008393129 | Maxxi Rip Thorax Interface 3ft is a device intended to capture respiratory effort from a patient |
| 00850008393112 | Maxxi Rip Thorax Interface 7ft is a device intended to capture respiratory effort from a patient |
| 00850008393105 | Maxxi Rip Adjustable inductive belt is a device intended to capture respiratory effort from a pa |
| 00850008393099 | Maxxi Rip XX-Large inductive belt is a device intended to capture respiratory effort from a pati |
| 00850008393082 | Maxxi Rip X-Large inductive belt is a device intended to capture respiratory effort from a patie |
| 00850008393075 | Maxxi Rip Large inductive belt is a device intended to capture respiratory effort from a patient |
| 00850008393068 | Maxxi Rip pediatric inductive belt is a device intended to capture respiratory effort from a pat |
| 00850008393051 | Maxxi Rip Infant inductive belt is a device intended to capture respiratory effort from a patien |
| 00850008393044 | Gold cup electrodes 48" length, (5 electrodes/pack) |
| 00850008393037 | Gold cup electrodes 48" length, (5 electrodes/pack) |
| 00850008393020 | Gold cup electrodes 60" length, (5 electrodes/pack) |
| 00850008393013 | Gold cup electrodes 96" length, (5 electrodes/pack) |
| 00850008393006 | Gold cup electrodes 96" length, (5 electrodes/pack) |
| 00867975000295 | Gold cup electrodes 60" length, (5 electrodes/pack) |
| 00850008393297 | The Maxxi Position Sensor is intended for use with the polysomnograph system to acquire the body |
| 00850008393310 | Disposable AgCl cup electrodes 96" length, (5 electrodes/pack) |
| 00850008393303 | Disposable AgCl cup electrodes 60" length, (5 electrodes/pack) |
| 00850008393341 | The Maxxi Flow Sensor is a thermocouple intended to acquire the respiratory signals |
| 00850008393334 | The Maxxi Flow Sensor is a thermocouple intended to acquire the respiratory signals |
| 00850008393327 | The Maxxi Flow Sensor is a thermocouple intended to acquire the respiratory signal |
| 00850008393365 | Reusable AgCl cup electrodes 96" length, (5 electrodes/pack) |
| 00850008393358 | Reusable AgCl cup electrodes 60" length, (5 electrodes/pack) |
| 00850008393396 | Maxxi Cannula is a two-pronged device used to acquire breathing pressure to sleep testing device |
| 00850008393389 | Maxxi Cannula is a two-pronged device used to acquire breathing pressure to sleep testing device |
| 00850008393372 | Maxxi Cannula is a two-pronged device used to acquire breathing pressure to sleep testing 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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