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
06926347900497POSTUREShenzhen Brav Electronic Technologies Co., Ltd.DXN2026-06-09
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00850086928008SENSINEL™ CPM BASE STATIONAnalog Devices, Inc.DSB2026-06-03
00850086928015SENSINEL™ CPM WEARABLEAnalog Devices, Inc.DSB2026-06-03
00850086928022SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DSB2026-06-03
00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DSB2026-06-03
06953825911041ELERAShenzhen Urion Technology Co., LtdDXN2026-06-03
06953825911188sakerplusShenzhen Urion Technology Co., LtdDXN2026-06-03
06953825911218AlphamedShenzhen Urion Technology Co., LtdDXN2026-06-03
06953825911225AlphamedShenzhen Urion Technology Co., LtdDXN2026-06-03
06953825911232AlphamedShenzhen Urion Technology Co., LtdDXN2026-06-03
06953825911249KPMNShenzhen Urion Technology Co., LtdDXN2026-06-03
06976528061608Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-03
06976528061615Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-03
06931973410890CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-06-02
06932825303216TeleRPMGuangdong Transtek Medical Electronics Co.,LtdDXN2026-06-02
08720256776567Corsano CardioWatch 287-2 SystemCorsano Health B.V.DQA2026-06-02
08720256776567Corsano CardioWatch 287-2 SystemCorsano Health B.V.DXN2026-06-02
06920485308450BSXMEDShenzhen BSX Technology Electronics Co., Ltd.DQA2026-06-01
06920485308467BSXMEDShenzhen BSX Technology Electronics Co., Ltd.DXN2026-06-01
06976528060335Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-01
06976528060342Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-01
06976528060359Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-01
06976528060366Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-01
06976528060373Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-01
06976528060380Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-01
06977093190052NAGuangdong Xinyu Electronic and Technology Co., Ltd.DXN2026-06-01
06932825306088PulseGuangdong Transtek Medical Electronics Co.,LtdDXN2026-05-29
06932825306132PulseGuangdong Transtek Medical Electronics Co.,LtdDXN2026-05-29
10884521855397NellcorCovidien LPDQA2026-05-29