MESI ABPI MD 301-000080

GUDID 03830059850366

The MESI ABPI MD is an automated wireless ankle-brachial index measuring device for screening patients for Peripheral Arterial Disease (PAD/LEAD). The device is intended to perform, view and store ankle-brachial index (ABI) measurements of adult patients –patients in the PAD risk group.

MESI d.o.o.

Noninvasive ankle brachial pressure index measurement unit

• Primary Device ID: 03830059850366
• NIH Device Record Key: 30b5c7f7-c25c-4783-8bb5-ed5be5cc405e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MESI ABPI MD
• Version Model Number: ABPIMDD
• Catalog Number: 301-000080
• 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	03830059850366 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172655

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: 2021-07-19The MESI ABPI MD is an automated wireless ankle-brachial index measuring device for screening patients for Peripheral Arterial Disease (PAD/LEAD). The device is intended to perform, view and store ankle-brachial index (ABI) measurements of adult patients –patients in the PAD risk group.
• 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