FDA.reportPublic FDA data

Horizon XVu

Primary DI
07290102932771
Brand
Horizon XVu
Company
MENNEN MEDICAL LTD.
Model
115V
Catalog number
960-800-310
Device description
Computerized Hemodynamic monitoring 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
07290102932771PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290102932771072901029327717290102932771

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac catheterization laboratory computerA dedicated computer designed to calculate, store, and analyse haemodynamic parameters, and other cardiac-related measurements, based on data from catheterization laboratory monitoring/recording. Such data can be pressure measurements that are converted into useful parameters, e.g., cardiac output, pressure gradients, valve areas, shunt flows, vascular resistance, diastolic filling period or systolic ejection period. The computer may store these values chronologically, along with other physiologic events that occur during the procedure. This GMDN code may reflect old technology; its functions may be performed using off-the-shelf computer ware and dedicated software.

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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