MESI mTABLET ABI 301-003015

GUDID 03830059851141

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.

MESI d.o.o.

Noninvasive ankle brachial pressure index measurement unit
Primary Device ID03830059851141
NIH Device Record Key2a109c9c-8357-48d3-958a-5a8dc6981c8f
Commercial Distribution StatusIn Commercial Distribution
Brand NameMESI mTABLET ABI
Version Model NumberMTABSYSABI
Catalog Number301-003015
Company DUNS500719478
Company NameMESI d.o.o.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103830059851141 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JOMPlethysmograph, Photoelectric, Pneumatic Or Hydraulic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-19
Device Publish Date2021-07-09

Devices Manufactured by MESI d.o.o.

03830059851103 - MESI mTABLET ECG2023-11-29 The MESI mTABLET ECG is a portable 12-lead resting ECG system for screening cardiac abnormalities. The system is intended for ac
03830059851523 - MESI mTABLET TBI2022-05-03 Wireless Toe Brachial Index System
03830059850366 - MESI ABPI MD2021-07-19 The MESI ABPI MD is an automated wireless ankle-brachial index measuring device for screening patients for Peripheral Arterial
03830059851141 - MESI mTABLET ABI2021-07-19The 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.
03830059851141 - MESI mTABLET ABI2021-07-19 The MESI mTABLET ABI is an automated wireless ankle-brachial index measuring system for screening patients for Peripheral Arteri

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