BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    CNAP® Monitor 500

    DI: 09120073931085 · Model: V1.4 · CNSystems Medizintechnik AG
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    CNAP® Monitor 500
    Primary DI
    09120073931085
    Version / Model
    V1.4
    Catalog Number
    21-FHCN-15513
    Company Name
    CNSystems Medizintechnik AG
    Labeler DUNS
    303562672
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-06-28
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    40892a77-93ce-4bab-b51e-1236170019a2
    Distribution End Date
    2017-09-21

    Device Description

    SET of: 09120073930934, CNAP® Monitor 500, Main Unit including quick Guide 09120073930767, CNAP® controller set, incl. 09120073930774 CNAP® Controller and 09120073930088 Fixture for CNAP® controller, adapter between 09120073930774 CNAP® Controller and 09120073930354 CNAP® forearm fixing cuff 09120073930354, CNAP® forearm fixing cuff, for fixing 09120073930774 CNAP® Controller 09120073930095, 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 output 09120073930033, BP Wave Out: CNAP® transducer cable, Unit; grey; adapter to interface cable 09120073930293, Operator's Manual, 09120073930668, CNAP® Component Organizer Set for CNAP® Monitor, 09120073930798 CNAP® double finger cuff mounting bracket together with 09120073930781 CNAP® controller mounting bracket NBP cuffs: 10840935102236, All Purpose Cuff, General, Large Adult, 98-0099-08, 20-FMA-15450 10840935102168, All Purpose Cuff, General, Adult 98-0097-10, 20-FMA-15350 10840935102113, All Purpose Cuff, General, Small Adult, 98-0095-09, 20-FMA-15250 10840935102052, All Purpose Cuff, General, Child, 98-0093-06, 20-FMA-15150 Patient Hose, 3 Meter, Rectus Fittings, 98-0028-00, 20-FMA-05050 Power 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

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    Yes
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    DXN System, Measurement, Blood-Pressure, Non-Invasive

    GMDN Terms

    Code Name
    61237 Noninvasive haemodynamic monitoring system

    Identifiers

    Type ID
    Primary 09120073931085

    Customer Contacts

    Phone
    +4331672345633
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K082599 000

    Storage Conditions

    Type
    Handling Environment Temperature
    Temperature Range
    10 – 40 Degrees Celsius
    Type
    Handling Environment Humidity
    Temperature Range
    15 – 85 Percent (%) Relative Humidity
    Type
    Handling Environment Atmospheric Pressure
    Temperature Range
    64.7 – 106 KiloPascal