FDA.reportPublic FDA data

TASK FORCE® MONITOR 3040i SET

Primary DI
09120073930712
Brand
TASK FORCE® MONITOR 3040i SET
Company
CNSystems Medizintechnik AG
Model
V2
Catalog number
03141
Device description
"Type 3040i , SET of: 09120073930644, TASK FORCE® MONITOR, Main Unit (incl. ContBP)09120073930446, ECG cable, 2.5m, ECG cable with protection against defibrillation, ""double nose"" connector09120073930507, ICG cable, 2.5m, ICG cable with protection against defibrillation, ""double nose"" connector09120073930460; 20pcs., Set of electrodes; Set include 4ECG electrodes, 3 ICG electrodes and one grounding pad09120073930675, Flying-V - finger cuff (large)09120073930682, Flying-V - finger cuff (medium)09120073930699, Flying-V - finger cuff (small)09120073930521, 2.5m, Air hose incl. 2x Rectus connector09120073930562, Flying-V Forearm fixing cuff, for Vascular Unloading device (arm fixation cuff contBP module)NBP cuffs:10840935102250, Cuff, AllPurpose, General, Large Adult, 98-0099-19, 30-FEMA-1545010840935102182, Cuff, AllPurpose, General, Adult, 98-0097-30, 30-FEMA-15350040437180041338, IEEE 1394 (FireWire) cable, 6/6 pin, 1,8mElectric supply wire, 3m,Interpower, grounded plug09120073930590, Instruction manual English USA04046938268248, Arm sling"
Published
2017-06-29
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
K014063000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K014063000TASK FORCE MONITOR 3040Cnsystems Medizintechnik GmbH2002-02-07DSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09120073930712PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09120073930712091200739307129120073930712

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

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

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