FDA.reportPublic FDA data

EMS-XL

Primary DI
07290102933082
Brand
EMS-XL
Company
MENNEN MEDICAL LTD.
Model
64 Ch. Console System
Catalog number
965-100-046
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
07290102933082PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290102933082072901029330827290102933082

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

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Primary DI, Brand, Company table
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