MESI mTABLET TBI
Basic Information
- Brand Name
- MESI mTABLET TBI
- Primary DI
- 03830059851523
- Version / Model
- MTABSYSTBI
- Catalog Number
- 301-003767
- Company Name
- MESI d.o.o.
- Labeler DUNS
- 500719478
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-04-25
- Public Version
- 2
- Public Version Date
- 2023-11-22
- Public Version Status
- Update
- Public Device Record Key
- d847825c-17de-4870-8d64-7c157128c6c9
Device Description
The MESI mTABLET TBI is an automated wireless Toe-Brachial Index measuring system for screening patients for Peripheral Arterial Disease (PAD/LEAD). The system is intended to perform, view, and store toe-brachial index (TBI) measurements of adult patients - patients in the PAD risk group - especially diabetic, renal, and elder patients who may suffer from calcified vessels. It is a wireless system that is comprised of a wireless medical tablet system, a toe blood pressure module, two tubeless blood pressure cuff modules, and a 4-port charging station module. MESI mTABLET TBI is intended to be used in a professional clinical environment by trained healthcare personnel who understand the principle of toe-brachial index (TBI) measurement and are able to place arm cuffs, digit cuffs and photoplethysmographic (PPG) probes on the patient body, as well as able to verify that these accessories are working as intended and to start the measurement process.
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
- Yes
- 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 |
|---|---|---|---|---|
| 16986 | Automatic-inflation electronic sphygmomanometer, portable, finger | An electrically-powered device designed to noninvasively measure blood pressure using a self-contained software program that regulates automatic finger-cuff inflation and measurement cycles. The cuff detects minute arterial volume changes in conjunction with an inflatable bladder which exerts pressure (counterpressure) just sufficient to equal the arterial pressure. The device typically displays current heart rate in addition to systolic and diastolic blood pressures. This device is designed to be portable (e.g., hand-held or carried in a pouch) and is often used for emergency services or home blood pressure monitoring. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03830059851523 | GS1 |
Customer Contacts
- Phone
- +38616203487
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K213730 | 000 |