Tesla M3 Remote Monitor 5450012

GUDID EMIP54500120

MIPM Mammendorfer Institut für Physik und Medizin GmbH

MRI-patient physiologic monitoring system

• Primary Device ID: EMIP54500120
• NIH Device Record Key: 1acb32e0-1ecb-4a9e-b3c4-56d91962a29b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tesla M3 Remote Monitor
• Version Model Number: Tesla M3 Remote Monitor
• Catalog Number: 5450012
• Company DUNS: 324416379
• Company Name: MIPM Mammendorfer Institut für Physik und Medizin GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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: +49814592090
• Email: info@mipm.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EMIP54500120 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142032

FDA Product Code

• MWI: Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

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: 2019-11-19
• Device Publish Date: 2019-11-11

On-Brand Devices [Tesla M3 Remote Monitor]

• EMIP54500120: Tesla M3 Remote Monitor
• 04255629200492: Tesla M3 Remote Monitor