FDA.reportPublic FDA data

TFM Maintenance Kit 3040i

Primary DI
09120073930491
Brand
TFM Maintenance Kit 3040i
Company
CNSystems Medizintechnik AG
Model
V1.0
Catalog number
HHSE0004
Device description
Set: 60_1: 2Stk., Pumpenlagerung Boden/Deckel, Eurofoam Protect, KF55B1 weiß, Zuschnitt gemäß Zeichnung V2.060_2: Pumpenlagerung Mittelteil, Eurofoam Protekt, KF55B1 weiß, Zuschnitt gemäß Zeichnung V2.060_3: Schaumstoffkleber, Foamspray 2203, 1000g Dose (für ContBP Pumpenlagerung)60_4: Kabelbinder natur, 144x2,5mm, Nylon 66 (für ContBP-Pumpenstutzen und OszBP Pumpenbefestigung)60_5: Schwarzer, Rev 02, ContBP-Pumpe 7s52102 SP 600 EC-LC 12 V60_6: PU-Schlauch DM6/4, 100m transparent (für Pumpe 0,215 )60_7: ContBP Pumpenkabel assembliert deakon450_06: Schwarzer, 7K73051 Pumpe SP V 6TC27S RO-D 6VDC (für OszBP)450_07: Kohritsu, SV-999, Solenoid valve 6V, DC 0,6W (Hauptventil für OszBP)450_10: Zellkautschuk Stärke 6mm-7mm, schwarz, f. OszBP Pumpenlagerung, 25x25mm450_11: Moosgummi Platte Stärke 2mm, grau, f. OszBP Pumpenlagerung (6V)450_12: Kabelbinder natur, 144x2,5mm, Nylon 66 (für ContBP-Pumpenstutzen und OszBP Pumpenbefestigung)450_13: Richmeg, RG-V-0520B, Solenoid valve (Backupventil für OszBP)
Published
2016-10-27
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
09120073930491PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09120073930491091200739304919120073930491

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).

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
303562672
Device count
1
Lot or batch
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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