MESI mTABLET TBI

Primary DI
03830059851523
Brand
MESI mTABLET TBI
Company
MESI d.o.o.
Model
MTABSYSTBI
Catalog number
301-003767
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.
Published
2022-04-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

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
K213730000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213730000MESI mTABLET TBI diagnostic system, MESI mTABLET TBIMesi, Development of Medical Devices, Ltd.; Mesi D.O.O.2022-04-21JOM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03830059851523PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03830059851523038300598515233830059851523

GMDN Terms#

Term, Definition table
TermDefinition
Automatic-inflation electronic sphygmomanometer, portable, fingerAn 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+38616203487info@mesimedical.com

Regulatory Flags#

DUNS number
500719478
Device count
1
Serial number
true
Manufacturing date on label
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
03830059850366MESI ABPI MDABPIMDD301-0000802021-07-09
03830059851141MESI mTABLET ABIMTABSYSABI301-0030152021-07-09

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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B322G0011ANS1 SoftwareLD TECHNOLOGY, LLCJOM2024-03-05
B322H0011LD-EKGLD TECHNOLOGY, LLCJOM2024-03-05
05051968035370DOPPLEXHUNTLEIGH HEALTHCARE LIMITEDJOM2022-10-10
03830059850366MESI ABPI MDMESI d.o.o.JOM2021-07-09
03830059851141MESI mTABLET ABIMESI d.o.o.JOM2021-07-09
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00860446000312APG Air-PlethysmographACI MEDICAL LLCJOM2016-09-24
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