Wireless ECG Sensor for Tesla M3 5300028

GUDID EMIP53000280

MIPM Mammendorfer Institut für Physik und Medizin GmbH

Electrocardiographic lead set, reusable

• Primary Device ID: EMIP53000280
• NIH Device Record Key: fc0a42c5-3ac0-4ba7-a07b-1b9a8e00cd39
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Wireless ECG Sensor for Tesla M3
• Version Model Number: Wireless ECG Sensor for Tesla M3
• Catalog Number: 5300028
• 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 Conditional
• 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	EMIP53000280 [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 [Wireless ECG Sensor for Tesla M3]

• EMIP53000280: Wireless ECG Sensor for Tesla M3
• 04255629200539: Wireless ECG Sensor for Tesla M3