FDA.reportPublic FDA data

VitaLogik4000

Primary DI
07290102932498
Brand
VitaLogik4000
Company
MENNEN MEDICAL LTD.
Model
12Lead,NI (Nellcor SpO2)
Catalog number
681-0R0-010
Device description
Patient monitor
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
DSIDetector And Alarm, Arrhythmia

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSIDetector And Alarm, ArrhythmiaCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290102932498PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290102932498072901029324987290102932498

GMDN Terms#

Term, Definition table
TermDefinition
Single-patient intensive/general healthcare physiologic monitoring systemAn assembly of electrically-powered devices designed for the continuous assessment of several vital physiologic parameters (e.g., ECG, blood pressure, heart rate, temperature, cardiac output, apnoea, and respiratory/anaesthetic gas concentrations) of one patient in intensive or general healthcare settings. It typically includes a central station monitor that receives, consolidates, and displays the information, and/or a bedside patient monitor; it often includes programmable alarms, portable radio transmitters, receivers, and antennas (telemetry systems) to allow monitoring during patient ambulation or transportation; it is not dedicated to neonatal use.

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
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
07290102932726MenntorBase unit791-000-0002016-09-24

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Primary DI, Brand, Company table
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