Narcotrend-Compact M

GUDID 04260497021063

MT MonitorTechnik GmbH & Co. KG

Electroencephalographic monitoring system, portable

• 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)