FDA.reportPublic FDA data

Finapres

Primary DI
08719326027654
Brand
Finapres
Company
Finapres Medical Systems B.V.
Model
Finger cuff size Small
Catalog number
FP_400202
Device description
Finger cuff size Small
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
DSBPlethysmograph, Impedance
DXNSystem, Measurement, Blood-Pressure, Non-Invasive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSBPlethysmograph, ImpedanceCardiovascular2
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K023338000
K023723000
K063111000
K141460000
K160967000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K023338000PORTAPRES AMBULATORY CONTINUOUS NON INVASIVE BLOOD PRESSURE MONITOR,MODEL-2Fms, Finapres Medical Systems BV2003-05-09DXN
K023723000FINOMETER NONINVASIVE HEMODYNAMIC MONITOR, MODEL 1Fms, Finapres Medical Systems BV2003-10-23DXN
K063111000FINOMETER MODEL-2 WITH ACCESSORIESFinapres Medical Systems B.V.2007-02-01DXN
K141460000FINAPRES NOVA NONINVASIVE HEMODYNAMIC MONITORFinapres Medical Systems B.V.2015-03-20DXN
K160967000Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.2017-04-18DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08719326027654PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08719326027654087193260276548719326027654

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
08719327003770FinapresFinger cuff size Large NCFP_4002242018-11-30
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
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

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