waveguard

GUDID B195CA069

eeg cap

eemagine Medical Imaging Solutions GmbH

Electroencephalographic electrode cap, reusable

• Primary Device ID: B195CA069
• NIH Device Record Key: cd06cf38-6ea1-4f10-872d-5d83f99db5fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: waveguard
• Version Model Number: CA-069
• Company DUNS: 313152485
• Company Name: eemagine Medical Imaging Solutions GmbH
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +493029048404
• Email: support@eemagine.com
• Phone: +493029048404
• Email: support@eemagine.com
• Phone: +493029048404
• Email: support@eemagine.com
• Phone: +493029048404
• Email: support@eemagine.com
• Phone: +493029048404
• Email: support@eemagine.com
• Phone: +493029048404
• Email: support@eemagine.com
• Phone: +493029048404
• Email: support@eemagine.com
• Phone: +493029048404
• Email: support@eemagine.com
• Phone: +493029048404
• Email: support@eemagine.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B195CA069 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110223

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: 2021-03-10
• Device Publish Date: 2021-03-02

On-Brand Devices [waveguard]

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• B195XE385C0: eeg cap accessories
• B195XE385: eeg cap accessories
• B195XE277: eeg cap accessories
• B195XE126: eeg cap accessories
• B195XE1255C0: eeg cap accessories
• B195XE1255A0: eeg cap accessories
• B195XE1254C0: eeg cap accessories
• B195XE1254A0: eeg cap accessories
• B195XE1253C0: eeg cap accessories
• B195XE1253A0: eeg cap accessories
• B195XE1252C0: eeg cap accessories
• B195XE1252A0: eeg cap accessories
• B195XE1251C0: eeg cap accessories
• B195XE1251A0: eeg cap accessories
• B195XE125: eeg cap accessories
• B195XC302: eeg cap
• B195XC301: eeg cap
• B195XC240REF0: eeg cap accessories
• B195XC240GND0: eeg cap accessories
• B195XC240EOG0: eeg cap accessories
• B195XC240BBB0: eeg cap accessories
• B195XC240: eeg cap accessories
• B195XC163: eeg cap accessories
• B195XC161: eeg cap accessories
• B195XC141: eeg cap accessories
• B195XC135: eeg cap accessories
• B195XC133: eeg cap accessories
• B195XC127: eeg cap accessories
• B195XC118: eeg cap accessories
• B195XC113: eeg cap accessories
• B195XC110: eeg cap accessories
• B195XC109: eeg cap accessories
• B195XC108: eeg cap accessories
• B195XC005: eeg cap accessories
• B195XC004: eeg cap accessories
• B195XC003: eeg cap accessories
• B195XC002: eeg cap accessories
• B195XC001: eeg cap accessories
• B195RC325: eeg cap accessories
• B195RC324: eeg cap accessories
• B195RC318: eeg cap accessories
• B195RC317: eeg cap accessories
• B195RC316: eeg cap accessories
• B195RC315: eeg cap accessories
• B195CS312: eeg cap
• B195CS311: eeg cap
• B195CS301: eeg cap
• B195CA430: eeg cap