FDA.reportPublic FDA data

Finapres

Primary DI
08719327007105
Brand
Finapres
Company
Finapres Medical Systems B.V.
Model
Finapres NOVA Main Unit NC
Catalog number
FP_910804
Device description
Finapres NOVA Main Unit NC
Published
2018-11-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
DQAOximeter
DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
DSBPlethysmograph, Impedance
DXNSystem, Measurement, Blood-Pressure, Non-Invasive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2
DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)Cardiovascular2
DSBPlethysmograph, ImpedanceCardiovascular2
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173916000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173916000Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.2018-11-06DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08719327007105PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08719327007105087193270071058719327007105

GMDN Terms#

Term, Definition table
TermDefinition
Patient monitoring system module, blood pressure, noninvasiveA small unit dedicated to the measurement of noninvasive blood pressure (indirect method) obtained through a standard sphygmomanometer cuff placed on the arm or leg. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device or a connected module rack. The parent device operates as a mainframe computer displaying the blood pressure parameter/information measured and provided by this module.

Regulatory Flags#

DUNS number
489470686
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08719327003763FinapresValsalva Assembly2022-05-25
08719327003770FinapresFinger cuff size Large NCFP_4002242018-11-30
08719327003787FinapresFinger cuff size Medium NCFP_4002232018-11-30
08719327003794FinapresFinger cuff size Small NCFP_4002222018-11-30
08719327007112FinapresFinapres NOVA Frontend Unit NCFP_9108042018-11-30
08719327007129FinapresHeight Correction Unit NCFP_9039032018-11-30
08719326027630FinapresFinger cuff size LargeFP_4002042016-09-24
08719326027647FinapresFinger cuff size MediumFP_4002032016-09-24
08719326027654FinapresFinger cuff size SmallFP_4002022016-09-24
08719327003640FinapresPP Height Correction UnitFP_9039022016-09-24
08719327003664FinapresFinapres NOVA Main UnitFP_9109012016-09-24
08719327003671FinapresFinapres NOVA Frontend UnitFP_9108012016-09-24
08719326027609FinapresECG ModuleFP_9049052016-09-24
08719326027616FinapresECG ModuleFP_9049042016-09-24
08719326027623FinapresECG ModuleFP_9049032016-09-24
08719326027661FinapresFinometer Model-2 115VFP_9019022016-09-24
08719326027678FinapresFinometer Model-2 230VFP_9019012016-09-24
08719326027685FinapresFinometer Model-2 Frontend Unit2016-09-24
08719326027692FinapresFM-M2 Analog Interface cableFP_9018052016-09-24
08719327003602FinapresFinometer Model-1 115VFP_9059022016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06946725538005APKAPK Technology Co.,Ltd.DQA2026-09-04
06946725548998APKAPK Technology Co.,Ltd.DQA2026-09-04
06946725572276APKAPK Technology Co.,Ltd.DQA2026-09-04
06920485308580P PANACAREShenzhen BSX Technology Electronics Co., Ltd.DXN2026-08-26
06944413835153Telemetry MonitorEdan Instruments, Inc.DXN2026-08-26
06944413835153Telemetry MonitorEdan Instruments, Inc.DSB2026-08-26
06944413835153Telemetry MonitorEdan Instruments, Inc.DRT2026-08-26
06944413835153Telemetry MonitorEdan Instruments, Inc.DQA2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.DXN2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.DSB2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.DRT2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.DQA2026-08-26
00634782101633Diagnostix™AMERICAN DIAGNOSTIC CORPDQA2026-08-25
00634782102265Advantage™AMERICAN DIAGNOSTIC CORPDXN2026-08-25
00810226442306ViveVIVE HEALTH LLCDXN2026-08-25
00856324008778PARAMEDSILEX GLOBAL LLCDXN2026-08-22
06971522821753LineshareShenzhen Finicare Co., LtdDXN2026-08-22
06971522821760LineshareShenzhen Finicare Co., LtdDXN2026-08-22
06924054300647Medical GuardianSHANGHAI BERRY ELECTRONIC TECH CO., LTD.DQA2026-08-21
06946725572221APKAPK Technology Co.,Ltd.DQA2026-08-21
06953825911805FOCUSED ADULT ADHD CLINICShenzhen Urion Technology Co., LtdDXN2026-08-19
06924054300913BERRY®SHANGHAI BERRY ELECTRONIC TECH CO., LTD.DQA2026-08-18
06924054300920BERRY®SHANGHAI BERRY ELECTRONIC TECH CO., LTD.DQA2026-08-18
06970404880000UpnMedShenzhen Upnmed Equipment Co.,Ltd.DQA2026-08-18
06970404880017UpnMedShenzhen Upnmed Equipment Co.,Ltd.DQA2026-08-18
06970404880024UpnMedShenzhen Upnmed Equipment Co.,Ltd.DQA2026-08-18
06970404880031UpnMedShenzhen Upnmed Equipment Co.,Ltd.DQA2026-08-18
09120073932778CNAP® ArmslingCNSystems Medizintechnik GmbHDXN2026-08-18
09120073932785CNAP® double finger cuff "small"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932792CNAP® double finger cuff "medium"CNSystems Medizintechnik GmbHDXN2026-08-18