FDA.reportPublic FDA data

CNAP® Monitor 500

Primary DI
09120073930385
Brand
CNAP® Monitor 500
Company
CNSystems Medizintechnik AG
Model
V1.5
Catalog number
21-FHCN-15511
Device description
Main Unit; include quick Guide
Published
2017-08-02
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
K082599000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082599000NON-INVASIVE CONTINUOUS BLOOD PRESSURE MONITORING SYSTEM CNAP MONITOR 500I, 500ATCnsystem Medizintechnik AG2008-10-17DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09120073930385PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09120073930385091200739303859120073930385

GMDN Terms#

Term, Definition table
TermDefinition
Noninvasive haemodynamic monitoring systemAn assembly of mains electricity (AC-powered) devices intended to be used for the noninvasive continuous measurement of arterial blood pressure, cardiac output, and other haemodynamic variables by automated radial arterial tonometry. It consists of a bracelet-like detection device worn on the wrist and an attached monitor with user interface. It is typically used in the operating arena or the intensive care unit (ICU).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity15 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure64.7 KiloPascal106 KiloPascal

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4331672345633service@cnsystems.com

Regulatory Flags#

DUNS number
303562672
Device count
1
DM exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09120073930026AUX: Analog Out connectorV3.020-FEKA-011002016-10-27
09120073930033BP Wave Out: CNAP® transducer cable V1.320-FFKA-012002016-10-27
09120073930040BP Wave Out: CNAP® transducer cable V1.320-FFKA-012012016-10-27
09120073930057BP Wave Out: CNAP® transducer cable V1.320-FFKA-012022016-10-27
09120073930064BP Wave Out: CNAP® transducer cable V1.320-FFKA-012032016-10-27
09120073930095CNAP® cableC20-FEKA-100412016-10-27
09120073930118CNAP® controller setV4.121-FHCN-167052017-08-07
09120073930125"CNAP® double finger cuff ""large"""V4.420-FVMA-15620E2016-10-27
09120073930132"CNAP® double finger cuff ""large"""V4.420-FVMA-15620M2016-10-27
09120073930149"CNAP® double finger cuff ""large"""V4.420-FVMA-156202016-10-27
09120073930156"CNAP® double finger cuff ""large"""V4.420-FVMA-15620U2016-10-27
09120073930163"CNAP® double finger cuff ""medium"""V4.420-FVMA-15520E2016-10-27
09120073930170"CNAP® double finger cuff ""medium"""V4.420-FVMA-15520M2016-10-27
09120073930187"CNAP® double finger cuff ""medium"""V4.420-FVMA-155202016-10-27
09120073930194"CNAP® double finger cuff ""medium"""V4.420-FVMA-15520U2016-10-27
09120073930200"CNAP® double finger cuff ""small"""V4.420-FVMA-15420E2016-10-27
09120073930217"CNAP® double finger cuff ""small"""V4.420-FVMA-15420M2016-10-27
09120073930224"CNAP® double finger cuff ""small"""V4.420-FVMA-154202016-10-27
09120073930231"CNAP® double finger cuff ""small"""V4.420-FVMA-15420U2016-10-27
09120073930255CNAP® monitor mount - cartV1.221-FEZU-050102016-10-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00093764604744A&D MedicalA&D COMPANY, LIMITEDDXN2026-09-25
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06920485308580P PANACAREShenzhen BSX Technology Electronics Co., Ltd.DXN2026-08-26
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00634782102265Advantage™AMERICAN DIAGNOSTIC CORPDXN2026-08-25
00810226442306ViveVIVE HEALTH LLCDXN2026-08-25
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06953825911805FOCUSED ADULT ADHD CLINICShenzhen Urion Technology Co., LtdDXN2026-08-19
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
09120073932808CNAP® double finger cuff "large"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932815CNAP® double finger cuff "small"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932822CNAP® double finger cuff "medium"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932839CNAP® double finger cuff "large"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932846CNAP® double finger cuff "small"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932853CNAP® double finger cuff "medium"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932860CNAP® double finger cuff "large"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932877CNAP® double finger cuff "small"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932884CNAP® double finger cuff "medium"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932891CNAP® double finger cuff "large"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073933034CNAP® Armsling "small"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073933041TFC Armsling "small"CNSystems Medizintechnik GmbHDXN2026-08-18