Neurovirtual PV1010-33CI

GUDID 00850008393044

Gold cup electrodes 48" length, (5 electrodes/pack)

NEUROVIRTUAL USA, INC.

Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode

• Primary Device ID: 00850008393044
• NIH Device Record Key: db2331f6-daf0-4f3e-81e7-2ef47ca57b40
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Neurovirtual
• Version Model Number: Maxxi Gold Electrode 48"
• Catalog Number: PV1010-33CI
• 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: 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

Operating and Storage Conditions

• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 40 Degrees Celsius and 104 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 40 Degrees Celsius and 104 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 40 Degrees Celsius and 104 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 40 Degrees Celsius and 104 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 40 Degrees Celsius and 104 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 40 Degrees Celsius and 104 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 40 Degrees Celsius and 104 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 40 Degrees Celsius and 104 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 40 Degrees Celsius and 104 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 40 Degrees Celsius and 104 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 40 Degrees Celsius and 104 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 40 Degrees Celsius and 104 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 40 Degrees Celsius and 104 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 40 Degrees Celsius and 104 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 40 Degrees Celsius and 104 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 40 Degrees Celsius and 104 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850008393044 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163547

FDA Product Code

• GXY: Electrode, Cutaneous

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]

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• 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