FDA.reportPublic FDA data

CNAP® Monitor 500

Primary DI
09120073931085
Brand
CNAP® Monitor 500
Company
CNSystems Medizintechnik AG
Model
V1.4
Catalog number
21-FHCN-15513
Device description
"SET of: 09120073930934, CNAP® Monitor 500, Main Unit including quick Guide09120073930767, CNAP® controller set, incl. 09120073930774 CNAP® Controller and 09120073930088 Fixture for CNAP® controller, adapter between 09120073930774 CNAP® Controller and 09120073930354 CNAP® forearm fixing cuff09120073930354, CNAP® forearm fixing cuff, for fixing 09120073930774 CNAP® Controller09120073930095, CNAP® cable, 2.5m; interface 09120073930774 CNAP® controller to 09120073930750 CNAP® Monitor 500 09120073930132, CNAP® double finger cuff ""large"", sensor with Maximum Lifecycle (300h)09120073930170, CNAP® double finger cuff ""medium"", sensor with Maximum Lifecycle (300h)09120073930200, CNAP® double finger cuff ""small"", sensor with Maximum Lifecycle (300h)09120073931030, AUX: Analog out connector, connector for data analog output09120073930033, BP Wave Out: CNAP® transducer cable, Unit; grey; adapter to interface cable09120073930293, Operator's Manual, 09120073930668, CNAP® Component Organizer Set for CNAP® Monitor, 09120073930798 CNAP® double finger cuff mounting bracket together with 09120073930781 CNAP® controller mounting bracketNBP cuffs:10840935102236, All Purpose Cuff, General, Large Adult, 98-0099-08, 20-FMA-1545010840935102168, All Purpose Cuff, General, Adult 98-0097-10, 20-FMA-1535010840935102113, All Purpose Cuff, General, Small Adult, 98-0095-09, 20-FMA-1525010840935102052, All Purpose Cuff, General, Child, 98-0093-06, 20-FMA-15150Patient Hose, 3 Meter, Rectus Fittings, 98-0028-00, 20-FMA-05050Power cord USA Standard, 20-HEKA-01017, primary cord to external mains adapter External mains adapter, Manufacturer: M+R Multitronik GmbH, Niels-Bohr-Ring 28, 23568 Lübeck, Germany, phone: +49 451 60 99 5 0,2 pcs. Thermal paper, 20-HVZU-00258"
Published
2017-06-28
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
09120073931085PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09120073931085091200739310859120073931085

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 Atmospheric Pressure64.7 KiloPascal106 KiloPascal
Handling Environment Humidity15 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius

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

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