FDA UDI
In Commercial Distribution
🇺🇸 United States
MESI mTABLET ABI
DI: 03830059851141
·
Model: MTABSYSABI
·
MESI d.o.o.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MESI mTABLET ABI
- Primary DI
- 03830059851141
- Version / Model
- MTABSYSABI
- Catalog Number
- 301-003015
- Company Name
- MESI d.o.o.
- Labeler DUNS
- 500719478
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-07-09
- Public Version
- 1
- Public Version Date
- 2021-07-19
- Public Version Status
- New
- Public Device Record Key
- 2a109c9c-8357-48d3-958a-5a8dc6981c8f
Device Description
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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JOM | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic | Cardiovascular | 870.2780 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58928 | Noninvasive ankle brachial pressure index measurement unit | An automated, battery-powered, portable electronic device designed to calculate the ankle brachial pressure index (ABPI), used in the diagnosis of peripheral vascular disease (PVD), from simultaneous oscillometric measurement of the ankle and brachial blood pressure indices. It typically consists of a control/analysis/display unit with cuffs placed around an arm and one or both ankles; it uses integrated transducers to measure cuff pressure oscillations which represent the fluctuations of pressure in the underlying blood vessels. The device is typically operated by a healthcare professional. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03830059851141 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K201046 | 000 |