FDA.reportPublic FDA data

EMS-XL

Primary DI
07290102933075
Brand
EMS-XL
Company
MENNEN MEDICAL LTD.
Model
64 Ch. Mobile System
Catalog number
965-100-036
Device description
Cardiac electrophysiology analysis system
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQKComputer, Diagnostic, Programmable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQKComputer, Diagnostic, ProgrammableCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290102933075PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290102933075072901029330757290102933075

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac electrophysiology analysis systemAn assembly of devices designed to perform several diagnostic tests and therapeutic treatments of the heart in patients with arrhythmic or conduction disorders. It typically consists of a computerized workstation including a monitor, a printer or graphic recorder, a data recorder (e.g., optical or magnetic disk), and plug-in modules for signal amplification and/or conditioning. Signals are taken from external electrodes on the chest as well as from intracardiac electrodes and from blood pressure transducers. Device uses include analysis of the atrioventricular conduction system, defibrillator function, and the induction/termination of ventricular tachycardia.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+2152591020info@mmi.co.il

Regulatory Flags#

DUNS number
600019749
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290102932320VitaLogik4000 4000_3/5Lead_NI (Nellcor SpO2)681-0R0-0142016-09-24
07290102932474MenntorMX57 Top Assy(3/5ECG/Resp/2Temp/NIBP/2IBP/CO_N)751-000-2122016-09-24
07290102932481MenntorMX57 Top Assy (3/5ECG/Resp/2Temp/NIBP/2IBP/CO_M)751-000-2222016-09-24
07290102932498VitaLogik4000 12Lead,NI (Nellcor SpO2)681-0R0-0102016-09-24
07290102932504VitaLogik4000 3/5Lead,NI (Masimo SpO2)681-0R0-0242016-09-24
07290102932511VitaLogik4500 3/5/12Lead,2IBP (Nellcor SpO2)681-0R0-1102016-09-24
07290102932528VitaLogik4500 3/5Lead,2IBP (Nellcor)681-0R0-1142016-09-24
07290102932535VitaLogik4500 3/5/12Lead,2IBP (Masimo SpO2)681-0R0-1202016-09-24
07290102932542VitaLogik4500 3/5Lead,2IBP (Masimo SpO2)681-0R0-1242016-09-24
07290102932559VitaLogik4500 3/5/12Lead,4IBP (Nellcor SpO2)681-0R0-2102016-09-24
07290102932566VitaLogik4500 3/5/12Lead,4IBP (Masimo SpO2)681-0R0-2202016-09-24
07290102932603VitaLogik6000 3/5Lead,NI (Masimo SpO2)781-0R0-0242016-09-24
07290102932610VitaLogik6000 3/5/12Lead,2IBP (Nellcor SpO2)781-0R0-1102016-09-24
07290102932627VitaLogik6000 3/5Lead,2IBP (Nellcor SpO2)781-0R0-1142016-09-24
07290102932634VitaLogik6000 3/5/12Lead,2IBP (Masimo SpO2)781-0R0-1202016-09-24
07290102932641VitaLogik6000 3/5Lead,2IBP (Masimo SpO2)781-0R0-1242016-09-24
07290102932658VitaLogik6000 3/5/12Lead,4IBP (Nellcor SpO2)781-0R0-2102016-09-24
07290102932665VitaLogik6000 3/5/12Lead,4IBP (Masimo SpO2)781-0R0-2202016-09-24
07290102932689MenntorMX57 Module-Menntor751-000-0002016-09-24
07290102932696MenntorMX57 Top Assy(3/5ECG/Resp/2Temp/NIBP)Nelcor--Mennt751-000-0122016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05415067057952EnSite™ST. JUDE MEDICAL, INC.DQK2026-09-21
05415067057969EnSite™ST. JUDE MEDICAL, INC.DQK2026-09-21
00191506063214OPAL HDx™BOSTON SCIENTIFIC CORPORATIONDQK2026-09-20
00885403523512HemoSphere AltaBecton, Dickinson And CompanyDQK2026-09-18
00885403523536HemoSphere AltaBecton, Dickinson And CompanyDQK2026-09-18
00885403533764Smart Pressure ControllerBecton, Dickinson And CompanyDQK2026-09-18
00885403533771Smart Pressure Controller Accessory KitBecton, Dickinson And CompanyDQK2026-09-18
00199150062911N/AMEDTRONIC, INC.DQK2026-09-04
00198953213063ComboLabGe Medical Systems Information Technologies, Inc.DQK2026-08-26
00198953213087CardioLabGe Medical Systems Information Technologies, Inc.DQK2026-08-26
00198953213094Mac-LabGe Medical Systems Information Technologies, Inc.DQK2026-08-26
00198953243626MLCL Client SoftwareGe Medical Systems Information Technologies, Inc.DQK2026-08-26
05415067055651EnSite™ST. JUDE MEDICAL, INC.DQK2026-08-19
05415067055668EnSite™ST. JUDE MEDICAL, INC.DQK2026-08-19
05415067055675EnSite™ST. JUDE MEDICAL, INC.DQK2026-08-19
05415067055682EnSite™ST. JUDE MEDICAL, INC.DQK2026-08-19
00885403532040FloTracBecton, Dickinson And CompanyDQK2026-07-31
09349714010877MICROPACE PTY LIMITEDMICROPACE PTY LIMITEDDQK2026-07-21
17540262100150Change Healthcare Cardiology HemoChange Healthcare Canada CompanyDQK2026-07-21
17540262110166Change Healthcare Cardiology ECG ManagementChange Healthcare Canada CompanyDQK2026-07-21
17540262170054Change Healthcare Cardiology HemodynamicsChange Healthcare Canada CompanyDQK2026-07-21
00884838118898IECGPhilips Medizin Systeme Böblingen GmbHDQK2026-06-23
05415067055811EnSite™ST. JUDE MEDICAL, INC.DQK2026-06-01
00854277008197NorthStar Mapping SystemImricor Medical Systems, Inc.DQK2026-05-21
08719689142124QMAPP Fysicon B.V.DQK2026-05-19
08719689142131QMAPP Fysicon B.V.DQK2026-05-19
08719689142162QMAPP Fysicon B.V.DQK2026-05-19
08719689142179QMAPP Fysicon B.V.DQK2026-05-19
00843152100057IOPS Visionary SystemCenterline Biomedical, Inc.DQK2026-02-24
00195278343383CARESCAPE CENTRAL STATIONGe Medical Systems Information Technologies, Inc.DQK2026-02-11