FDA.reportPublic FDA data

MESI mTABLET ABI

Primary DI
03830059851141
Brand
MESI mTABLET ABI
Company
MESI d.o.o.
Model
MTABSYSABI
Catalog number
301-003015
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.
Published
2021-07-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
JOMPlethysmograph, Photoelectric, Pneumatic Or Hydraulic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOMPlethysmograph, Photoelectric, Pneumatic Or HydraulicCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201046000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201046000Automated ankle brachial pressure index measuring device, MESI mTABLET systemMesi D.O.O.; Mesi, Development of Medical Devices, Ltd.2020-12-11JOM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03830059851141PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03830059851141038300598511413830059851141

GMDN Terms#

Term, Definition table
TermDefinition
Noninvasive ankle brachial pressure index measurement unitAn 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
500719478
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03830059852216MESI mTABLET SPIROMTABSYSSPIRO2026-03-24
03830059853220MESI mTABLET ECG Extension, BANANA AHAECGSYSCS4 EN, BANANA AHA301-0005122025-03-10
03830059851103MESI mTABLET ECGMTABSYSECG301-0020072023-11-21
03830059851523MESI mTABLET TBIMTABSYSTBI301-0037672022-04-25
03830059850366MESI ABPI MDABPIMDD301-0000802021-07-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00862467000333PADnet XpressCollaborative Care Diagnostics, LLCJOM2026-02-04
08690020003017VitalScan ANSMedeia, Inc.JOM2025-02-05
08690020003031VitalScan HRVMedeia, Inc.JOM2025-02-05
B322G0011ANS1 SoftwareLD TECHNOLOGY, LLCJOM2024-03-05
B322H0011LD-EKGLD TECHNOLOGY, LLCJOM2024-03-05
05051968035370DOPPLEXHUNTLEIGH HEALTHCARE LIMITEDJOM2022-10-10
03830059851523MESI mTABLET TBIMESI d.o.o.JOM2022-04-25
03830059850366MESI ABPI MDMESI d.o.o.JOM2021-07-09
00884838093188Avalon Toco+ MP TransducerPhilips Medizin Systeme Böblingen GmbHJOM2021-03-08
00884838093195Avalon Ultrasound TransducerPhilips Medizin Systeme Böblingen GmbHJOM2021-03-08
00884838093201Avalon ECG/IUP TransducerPhilips Medizin Systeme Böblingen GmbHJOM2021-03-08
00884838093218Avalon Toco MP TransducerPhilips Medizin Systeme Böblingen GmbHJOM2021-03-08
00884838093225Avalon Toco+ TransducerPhilips Medizin Systeme Böblingen GmbHJOM2021-03-08
00191237000014SA-3000PMedicore Co., Ltd.JOM2019-04-10
10191237000011SA-3000PMedicore Co., Ltd.JOM2019-04-10
00191237000038Max PulseMedicore Co., Ltd.JOM2019-03-05
40191237000036Max PulseMedicore Co., Ltd.JOM2019-03-05
B322C0011TBL-ABILD TECHNOLOGY, LLCJOM2019-01-16
04051526846302MEDIMEDI MANUFACTURING, INC.JOM2018-11-20
04051526846463MEDIMEDI MANUFACTURING, INC.JOM2018-11-20
04051526849631MEDIMEDI MANUFACTURING, INC.JOM2018-11-20
04051526903616MEDIMEDI MANUFACTURING, INC.JOM2018-11-20
00636257188439MEDIMEDI MANUFACTURING, INC.JOM2018-11-20
00636257189085MEDIMEDI MANUFACTURING, INC.JOM2018-11-20
00817065022454HokansonD.E.HOKANSON, INC.JOM2017-12-12
05051968030429DOPPLEXHUNTLEIGH HEALTHCARE LIMITEDJOM2016-11-07
05051968030436DOPPLEXHUNTLEIGH HEALTHCARE LIMITEDJOM2016-11-07
00860446000312APG Air-PlethysmographACI MEDICAL LLCJOM2016-09-24
00862467000302PADnetCollaborative Care Diagnostics, LLCJOM2016-09-24
00816787020014DOPPLER MODEL 1050-C W/PPGPARKS MEDICAL ELECTRONICS, INC.JOM2016-09-24