MESI mTABLET ABI 301-003015

GUDID 03830059851141

The MESI mTABLET ABI is an automated wireless ankle-brachial index measuring system for screening patients for Peripheral Arterial Disease (PAD/LEAD). The system is intended to perform, viewing and storing ankle-brachial index (ABI) measurement of adult patients –patients in the PAD risk group. It is a wireless system which is comprised of a wireless medical tablet system, four tubeless blood pressure cuff modules and a 4-port charging station module.

MESI d.o.o.

Noninvasive ankle brachial pressure index measurement unit

• Primary Device ID: 03830059851141
• NIH Device Record Key: 2a109c9c-8357-48d3-958a-5a8dc6981c8f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MESI mTABLET ABI
• Version Model Number: MTABSYSABI
• Catalog Number: 301-003015
• 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	03830059851141 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201046

FDA Product Code

• JOM: Plethysmograph, Photoelectric, Pneumatic Or Hydraulic

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: 2021-07-19
• Device Publish Date: 2021-07-09

Devices Manufactured by MESI d.o.o.

• 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: 2021-07-19The MESI mTABLET ABI is an automated wireless ankle-brachial index measuring system for screening patients for Peripheral Arterial Disease (PAD/LEAD). The system is intended to perform, viewing and storing ankle-brachial index (ABI) measurement of adult patients –patients in the PAD risk group. It is a wireless system which is comprised of a wireless medical tablet system, four tubeless blood pressure cuff modules and a 4-port charging station module.
• 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