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 Noninvasive ankle brachial pressure index measurement unit Noninvasive ankle brachial pressure index measurement unit Noninvasive ankle brachial pressure index measurement unit Noninvasive ankle brachial pressure index measurement unit Noninvasive ankle brachial pressure index measurement unit Noninvasive ankle brachial pressure index measurement unit Noninvasive ankle brachial pressure index measurement unit Noninvasive ankle brachial pressure index measurement unit Noninvasive ankle brachial pressure index measurement unit Noninvasive ankle brachial pressure index measurement unit Noninvasive ankle brachial pressure index measurement unit 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