MESI mTABLET ECG Extension, BANANA AHA 301-000512

GUDID 03830059853220

The MESI mTABLET ECG is a portable 12-lead resting ECG system for screening cardiac abnormalities. The system is intended for acquiring, viewing, and storing signals from adult and pediatric patients. It is a wireless system that is comprised of the control unit (mTABLET) and diagnostic module (12-lead resting ECG) used solely in a professional clinical environment by trained healthcare personnel.

MESI d.o.o.

Electrocardiograph, professional, multichannel

• Primary Device ID: 03830059853220
• NIH Device Record Key: 8f8a0450-85cd-4cc3-a9dd-208dad8dd013
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MESI mTABLET ECG Extension, BANANA AHA
• Version Model Number: ECGSYSCS4 EN, BANANA AHA
• Catalog Number: 301-000512
• Company DUNS: 500719478
• Company Name: MESI d.o.o.
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03830059853220 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223670

FDA Product Code

• DPS: Electrocardiograph

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: 2025-03-18
• Device Publish Date: 2025-03-10

Devices Manufactured by MESI d.o.o.

• 03830059853220 - MESI mTABLET ECG Extension, BANANA AHA: 2025-03-18The MESI mTABLET ECG is a portable 12-lead resting ECG system for screening cardiac abnormalities. The system is intended for acquiring, viewing, and storing signals from adult and pediatric patients. It is a wireless system that is comprised of the control unit (mTABLET) and diagnostic module (12-lead resting ECG) used solely in a professional clinical environment by trained healthcare personnel.
• 03830059853220 - MESI mTABLET ECG Extension, BANANA AHA: 2025-03-18 The MESI mTABLET ECG is a portable 12-lead resting ECG system for screening cardiac abnormalities. The system is intended for ac
• 03830059851103 - MESI mTABLET ECG: 2023-11-29 The MESI mTABLET ECG is a portable 12-lead resting ECG system for screening cardiac abnormalities. The system is intended for ac
• 03830059851523 - MESI mTABLET TBI: 2022-05-03 Wireless Toe Brachial Index System
• 03830059850366 - MESI ABPI MD: 2021-07-19 The MESI ABPI MD is an automated wireless ankle-brachial index measuring device for screening patients for Peripheral Arterial
• 03830059851141 - MESI mTABLET ABI: 2021-07-19 The MESI mTABLET ABI is an automated wireless ankle-brachial index measuring system for screening patients for Peripheral Arteri