Narcotrend-Compact M

GUDID 04260497021063

MT MonitorTechnik GmbH & Co. KG

Electroencephalographic monitoring system, portable Electroencephalographic monitoring system Electroencephalographic monitoring system Electroencephalographic monitoring system Electroencephalographic monitoring system Electroencephalographic monitoring system Electroencephalographic monitoring system Electroencephalographic monitoring system Electroencephalographic monitoring system Electroencephalographic monitoring system Electroencephalographic monitoring system Electroencephalographic monitoring system

• Primary Device ID: 04260497021063
• NIH Device Record Key: 3707fc20-4151-4504-986f-55447d7395fb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Narcotrend-Compact M
• Version Model Number: T5
• 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: 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: 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	04260497021063 [Primary]
GS1	04260497021070 [Package]; Package: [2 Units]; In Commercial Distribution

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-03-26
• Device Publish Date: 2018-04-30

Devices Manufactured by MT MonitorTechnik GmbH & Co. KG

• 04260497021063 - Narcotrend-Compact M: 2019-03-26
• 04260497021063 - Narcotrend-Compact M: 2019-03-26
• 04260497026006 - Narcotrend Electrode: 2019-03-26
• 04260497025009 - Narcotrend Patient lead: 2018-07-06 1-channel (3 electrodes) Component of Narcotrend-Compact M (Primary DI Number: 04260497021063)
• 04260497025016 - Narcotrend Patient lead: 2018-07-06 2-channel (4 electrodes) Component of Narcotrend-Compact M (Primary DI Number: 04260497021063)