Enobio Dx

GUDID 18437017440670

This device is the spare part of Enobio Dx's component NG Pistim. NG Pistim is an EEG electrode to be used with Enobio Dx. Enobio Dx is a wireless battery-operated and portable electrophysiology sensor system for the recording of the electroencephalogram (EEG). It has been designated for use in a clinical environment or hospital. Enobio Dx use must be controlled by specialized medical personnel able to guarantee the correct recording.

NEUROELECTRICS BARCELONA SL

Electroencephalographic monitoring system

• Primary Device ID: 18437017440670
• NIH Device Record Key: 7fac2a3a-e0ea-4eb1-9c00-e220ae20e9f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Enobio Dx
• Version Model Number: NG Pistim - Component Replacement: Enobio Dx
• Company DUNS: 463756944
• Company Name: NEUROELECTRICS BARCELONA SL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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

• Phone: +34 932540366
• Email: support@neuroelectrics.com
• Phone: +34 932540366
• Email: support@neuroelectrics.com
• Phone: +34 932540366
• Email: support@neuroelectrics.com
• Phone: +34 932540366
• Email: support@neuroelectrics.com
• Phone: +34 932540366
• Email: support@neuroelectrics.com
• Phone: +34 932540366
• Email: support@neuroelectrics.com
• Phone: +34 932540366
• Email: support@neuroelectrics.com
• Phone: +34 932540366
• Email: support@neuroelectrics.com
• Phone: +34 932540366
• Email: support@neuroelectrics.com
• Phone: +34 932540366
• Email: support@neuroelectrics.com
• Phone: +34 932540366
• Email: support@neuroelectrics.com
• Phone: +34 932540366
• Email: support@neuroelectrics.com
• Phone: +34 932540366
• Email: support@neuroelectrics.com
• Phone: +34 932540366
• Email: support@neuroelectrics.com
• Phone: +34 932540366
• Email: support@neuroelectrics.com
• Phone: +34 932540366
• Email: support@neuroelectrics.com
• Phone: +34 932540366
• Email: support@neuroelectrics.com

Operating and Storage Conditions

• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	18437017440670 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162681

FDA Product Code

• GWQ: Full-Montage Standard 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: 2023-09-22
• Device Publish Date: 2023-09-14

On-Brand Devices [Enobio Dx]

• 18436612820283: Enobio Dx is a wireless battery-operated and portable electrophysiology sensor system for the re
• 18436612820276: Enobio Dx is a wireless battery-operated and portable electrophysiology sensor system for the re
• 18436612820269: Enobio Dx is a wireless battery-operated and portable electrophysiology sensor system for the re
• 18436612823024: This device is the spare part of Enobio Dx's component Kid Neoprene Headcap (size KS). It is use
• 18436612823017: This device is the spare part of Enobio Dx's component Kid Neoprene Headcap (size K). It is used
• 18436612823000: This device is the replacement of Enobio Dx's component Neoprene Headcap (size M, kit). It is us
• 08437017440406: This device is the spare part of Enobio Dx's component NG Pistim. NG Pistim is an EEG electrode
• 18437017440670: This device is the spare part of Enobio Dx's component NG Pistim. NG Pistim is an EEG electrode
• 08437017440376: This device is the spare part of Enobio Dx's component NG Geltrode. NG Geltrode is an EEG electr
• 18437017440656: This device is the spare part of Enobio Dx's component NG Geltrode. NG Geltrode is an EEG electr
• 08437017440383: This device is the spare part of Enobio Dx's component Foretrode. Foretrode is an EEG electrode
• 18437017440625: This device is the replacement of Enobio Dx's component Earclip. Foretrode is an EEG electrode t
• 18437017440618: This device is the replacement of Enobio Dx's component Earclip. Earclip is the electrical refer
• 08437017440390: This device is the spare part of Enobio Dx's component Drytrode. Drytrode is a dry electrode int
• 18436612823079: This device is the spare part of Enobio Dx's component Neoprene Headband. It is used to precisel
• 18436612823062: This device is the spare part of Enobio Dx's component Neoprene Headcap (size XL). It is used to
• 18436612823055: This device is the spare part of Enobio Dx's component Neoprene Headcap (size S). It is used to
• 18436612823048: This device is the spare part of Enobio Dx's component Neoprene Headcap (size M). It is used to
• 18436612823031: This device is the spare part of Enobio Dx's component Neoprene Headcap (size L). It is used to