Identity
- Trade Name
- MESI ABPI MD FDA UDI
- Generic Name
- Noninvasive ankle brachial pressure index measurement unit FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- ABPIMDD FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- 301-000080 FDA UDI
- Primary DI / UDI-DI
- 03830059850366 FDA UDI
- 510(k) Number
- K172655 FDA UDI
- FDA Product Code
- JOM FDA UDI
- GMDN Term
- Noninvasive ankle brachial pressure index measurement unit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2780 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Noninvasive ankle brachial pressure index measurement unit
Mesi Abpi Md by MESI d.o.o. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- MESI d.o.o.
Sources (1)
- FDA UDI 30b5c7f7-c25c-4783-8bb5-ed5be5cc405e 35 fields · synced Jun 8, 2026