FDA.reportPublic FDA data

Finapres

Primary DI
08719326027609
Brand
Finapres
Company
Finapres Medical Systems B.V.
Model
ECG Module
Catalog number
FP_904905
Device description
ECG Module FM-M2 Filtered
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
DXNSystem, Measurement, Blood-Pressure, Non-Invasive

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K063111000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063111000FINOMETER MODEL-2 WITH ACCESSORIESFinapres Medical Systems B.V.2007-02-01DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08719326027609PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08719326027609087193260276098719326027609

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
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
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
10850047516036KismeTruth Remote Patient MonitoringRemote Smart Health, LLCDXN2026-03-26
10840935111580Adult Orbit-K Cuff with Microphone, Bayonet, Reverse OrientationSUNTECH MEDICAL, INC.DXN2025-09-10
10840935111597Adult Plus Orbit-K Cuff with Microphone, Bayonet, Reverse OrientationSUNTECH MEDICAL, INC.DXN2025-09-10
10840935111603Large Adult Orbit-K Cuff with Microphone, Bayonet, Reverse OrientationSUNTECH MEDICAL, INC.DXN2025-09-10
08690020003017VitalScan ANSMedeia, Inc.DXN2025-02-05
10884450360634Meritrans DTXPlus®ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.DXN2024-09-06
09120073933027CNAP® Monitor 500 HDCNSystems Medizintechnik GmbHDXN2024-07-10
08720256776529Corsano CardioWatch 287-2 SystemCorsano Health B.V.DXN2024-06-19
10884450388164Merit Medical®ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.DXN2023-03-03
10840935110002SunTech MedicalSUNTECH MEDICAL, INC.DXN2022-12-14
09120073932990CNAP® Monitor 500 HDCNSystems Medizintechnik GmbHDXN2022-06-09
10884450385163Meritrans DTXPlus®ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.DXN2022-06-08
10884450323264Meritrans DTXPlus®ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.DXN2022-03-04
10884450619282Meritrans DTXPlus®ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.DXN2022-02-28
10884450619299Safedraw™ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.DXN2022-02-28
10884450621155Safedraw™ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.DXN2022-02-28
10884450371777Meritrans DTXPlus®ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.DXN2022-02-18
10884450371739Meritrans DTXPlus®ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.DXN2021-10-12
10884450372781Safedraw™ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.DXN2021-07-21
10840935109662Oscar 2SUNTECH MEDICAL, INC.DXN2021-04-09
10840935109679Oscar 2SUNTECH MEDICAL, INC.DXN2021-04-09
10840935109686Oscar 2SUNTECH MEDICAL, INC.DXN2021-04-09
G057IDBP8080IDEA HealthIDEA HEALTH LLCDXN2021-04-08
10884450544157Safedraw™ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.DXN2021-01-27
10193489012903MedlineMEDLINE INDUSTRIES, INC.DXN2020-12-16
10193489012927MedlineMEDLINE INDUSTRIES, INC.DXN2020-12-16
10193489012965MedlineMEDLINE INDUSTRIES, INC.DXN2020-12-16
10193489012934MedlineMEDLINE INDUSTRIES, INC.DXN2020-12-14
10193489012972MedlineMEDLINE INDUSTRIES, INC.DXN2020-12-14