Primary Device ID | 00850008393303 |
NIH Device Record Key | c8af95b5-7ebe-4c78-8697-9117fb49e54b |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Neurovirtual |
Version Model Number | Maxxi Gold AgCl Electrode 60" |
Catalog Number | SI2036 |
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 | true |
Lot Batch | true |
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 |
Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 40 Degrees Celsius and 104 Degrees Celsius |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 40 Degrees Celsius and 104 Degrees Celsius |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 40 Degrees Celsius and 104 Degrees Celsius |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 40 Degrees Celsius and 104 Degrees Celsius |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 40 Degrees Celsius and 104 Degrees Celsius |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 40 Degrees Celsius and 104 Degrees Celsius |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 40 Degrees Celsius and 104 Degrees Celsius |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 40 Degrees Celsius and 104 Degrees Celsius |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 40 Degrees Celsius and 104 Degrees Celsius |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 40 Degrees Celsius and 104 Degrees Celsius |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 40 Degrees Celsius and 104 Degrees Celsius |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 40 Degrees Celsius and 104 Degrees Celsius |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 40 Degrees Celsius and 104 Degrees Celsius |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 40 Degrees Celsius and 104 Degrees Celsius |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 40 Degrees Celsius and 104 Degrees Celsius |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 40 Degrees Celsius and 104 Degrees Celsius |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 40 Degrees Celsius and 104 Degrees Celsius |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 40 Degrees Celsius and 104 Degrees Celsius |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 40 Degrees Celsius and 104 Degrees Celsius |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 40 Degrees Celsius and 104 Degrees Celsius |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 40 Degrees Celsius and 104 Degrees Celsius |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 40 Degrees Celsius and 104 Degrees Celsius |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 40 Degrees Celsius and 104 Degrees Celsius |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 40 Degrees Celsius and 104 Degrees Celsius |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 40 Degrees Celsius and 104 Degrees Celsius |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 40 Degrees Celsius and 104 Degrees Celsius |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 40 Degrees Celsius and 104 Degrees Celsius |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 40 Degrees Celsius and 104 Degrees Celsius |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 40 Degrees Celsius and 104 Degrees Celsius |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 40 Degrees Celsius and 104 Degrees Celsius |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00850008393303 [Primary] |
GXY | Electrode, Cutaneous |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-08-18 |
Device Publish Date | 2020-08-10 |
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 |
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 |