Narcotrend Patient lead

GUDID 04260497025009

1-channel (3 electrodes) Component of Narcotrend-Compact M (Primary DI Number: 04260497021063)

MT MonitorTechnik GmbH & Co. KG

Electroencephalographic monitoring system, portable

• Primary Device ID: 04260497025009
• NIH Device Record Key: bba6e688-cb68-484e-9b7e-50e89c79ec40
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Narcotrend Patient lead
• Version Model Number: PKM1
• Company DUNS: 388136913
• Company Name: MT MonitorTechnik GmbH & Co. KG
• 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: true
• Serial Number: false
• Manufacturing Date: true
• 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

Customer Support Contacts

• Phone: +494192201753
• Email: info@monitortechnik.de
• Phone: +494192201753
• Email: info@monitortechnik.de
• Phone: +494192201753
• Email: info@monitortechnik.de
• Phone: +494192201753
• Email: info@monitortechnik.de
• Phone: +494192201753
• Email: info@monitortechnik.de
• Phone: +494192201753
• Email: info@monitortechnik.de
• Phone: +494192201753
• Email: info@monitortechnik.de
• Phone: +494192201753
• Email: info@monitortechnik.de
• Phone: +494192201753
• Email: info@monitortechnik.de
• Phone: +494192201753
• Email: info@monitortechnik.de
• Phone: +494192201753
• Email: info@monitortechnik.de
• Phone: +494192201753
• Email: info@monitortechnik.de

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260497025009 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033543

FDA Product Code

• OMC: Reduced- 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: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-05-09

On-Brand Devices [Narcotrend Patient lead]

• 04260497025016: 2-channel (4 electrodes) Component of Narcotrend-Compact M (Primary DI Number: 0426049702106
• 04260497025009: 1-channel (3 electrodes) Component of Narcotrend-Compact M (Primary DI Number: 04260497021063