FDA.reportPublic FDA data

Finapres

Primary DI
08719327003770
Brand
Finapres
Company
Finapres Medical Systems B.V.
Model
Finger cuff size Large NC
Catalog number
FP_400224
Device description
Finger cuff size Large 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
08719327003770PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08719327003770087193270037708719327003770

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08719327003763FinapresValsalva Assembly2022-05-25
08719327003787FinapresFinger cuff size Medium NCFP_4002232018-11-30
08719327003794FinapresFinger cuff size Small NCFP_4002222018-11-30
08719327007105FinapresFinapres NOVA Main Unit NCFP_9108042018-11-30
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
08800096401772Auto Blood Pressure MeterSEERS.Co.,LtdDXN2026-05-13
08052990320318MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2026-04-03
08052990320325MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2026-04-03
08052990320387MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2026-04-03
08052990320479MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2026-04-03
08052990320561MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2026-04-03
08052990320585MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2026-04-03
08052990320691MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2025-12-19
08052990320707MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2025-12-19
08809988780049Xandar Kardian Vital Sign Monitoring Sensor (Model: XK300-E)Xandar Kardian Korea Inc.DRT2025-12-04
G096MNKS2NORAC30MEDALinkRising Eagle Medical LLCDQA2025-10-08
08052990321704MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2025-02-27
08690020003017VitalScan ANSMedeia, Inc.DXN2025-02-05
08052990320264MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2024-11-25
08052990320271MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2024-11-25
08052990322084MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2024-11-25
08052990322213MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2024-11-25
07630002800754HAMILTON-T1Hamilton Medical AGDQA2024-08-21
07640121880988103149 Calibration GasSenTec AGDQA2024-07-05
07640121880995103164 tCOM+SenTec AGDQA2024-07-05
07640121881008103420 Sensor Adapter Cable (Regular)SenTec AGDQA2024-07-05
07640121881015103421 Sensor Adapter Cable (Long)SenTec AGDQA2024-07-05
07640121881022103422 Sensor Adapter Cable (Extra Long)SenTec AGDQA2024-07-05
08720256776529Corsano CardioWatch 287-2 SystemCorsano Health B.V.DXN2024-06-19
08720256776529Corsano CardioWatch 287-2 SystemCorsano Health B.V.DQA2024-06-19
07649996477019Sleepiz One+Sleepiz AGDRT2024-05-14
08809988780001Xandar Kardian Vital Sign Monitoring Sensor (Model: XK300)Xandar Kardian Korea Inc.DRT2024-01-19
08052990321711MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2024-01-04
G096MNKS2SADT0MEDALinkRising Eagle Medical LLCDQA2023-11-08
G096MNKS2SNEO0MEDALinkRising Eagle Medical LLCDQA2023-11-08