FDA.reportPublic FDA data

"CNAP® double finger cuff ""large"""

Primary DI
09120073930132
Brand
"CNAP® double finger cuff ""large"""
Company
CNSystems Medizintechnik AG
Model
V4.4
Catalog number
20-FVMA-15620M
Device description
Unit, with Maximum Lifecycle (300h)
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
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
09120073930132PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09120073930132091200739301329120073930132

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
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
09120073930262CNAP® monitor mountV1.021-FEZU-152022016-10-27

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