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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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CNAP® Monitor 500 - 09120073931122

SET of: 09120073930385, CNAP® Monitor 500, Main Unit including quick Guide 09120073930118, CNAP® controller set, incl. 09120073930101, CNAP® Controller and 09120073930088, Fixture for CNAP® controller, adapter between 09120073930101 CNAP® Controller and 09120073930354 CNAP® forearm fixing cuff 09120073930354, CNAP® forearm fixing cuff, for fixing 09120073930101 CNAP® Controller 09120073930095, CNAP® cable, 2.5m; interface 09120073930101 CNAP® controller to 09120073930385 CNAP® Monitor 500 09120073930156, CNAP® double finger cuff "large", sensor with Unlimited Lifecycle (600h) 09120073930194, CNAP® double finger cuff "medium", sensor with Unlimited Lifecycle (600h) 09120073930231, CNAP® double finger cuff "small", sensor with Unlimited Lifecycle (600h) 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 USA, 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
CNSystems Medizintechnik AG
V1.5
Not in Commercial Distribution

  • 09120073931122 ()
21-FHCN-15527

  • Noninvasive haemodynamic monitoring system

CNAP® Monitor 500 - 09120073931115

SET of: 09120073930385, CNAP® Monitor 500, Main Unit including quick Guide 09120073930118, CNAP® controller set, incl. 09120073930101, CNAP® Controller and 09120073930088, Fixture for CNAP® controller, adapter between 09120073930101 CNAP® Controller and 09120073930354 CNAP® forearm fixing cuff 09120073930354, CNAP® forearm fixing cuff, for fixing 09120073930101 CNAP® Controller 09120073930095, CNAP® cable, 2.5m; interface 09120073930101 CNAP® controller to 09120073930385 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)) 09120073930217, 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 USA, 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
CNSystems Medizintechnik AG
V1.5
Not in Commercial Distribution

  • 09120073931115 ()
21-FHCN-15526

  • Noninvasive haemodynamic monitoring system

CNAP® Monitor 500 - 09120073931108

SET of: 09120073930385, CNAP® Monitor 500, Main Unit including quick Guide 09120073930118, CNAP® controller set, incl. 09120073930101, CNAP® Controller and 09120073930088, Fixture for CNAP® controller, adapter between 09120073930101 CNAP® Controller and 09120073930354 CNAP® forearm fixing cuff 09120073930354, CNAP® forearm fixing cuff, for fixing 09120073930101 CNAP® Controller 09120073930095, CNAP® cable, 2.5m; interface 09120073930101 CNAP® controller to 09120073930385 CNAP® Monitor 500 09120073930125, CNAP® double finger cuff "large", sensor with Extended Lifecycle (150h) 09120073930163, CNAP® double finger cuff "medium", sensor with Extended Lifecycle (150h) 09120073930200, CNAP® double finger cuff "small", sensor with Extended Lifecycle (150h) 09120073931351, 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 USA, 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
CNSystems Medizintechnik AG
V1.5
Not in Commercial Distribution

  • 09120073931108 ()
21-FHCN-15525

  • Noninvasive haemodynamic monitoring system

CNAP® Monitor 500 - 09120073931092

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 09120073930125, CNAP® double finger cuff "large", sensor with Unlimited Lifecycle (600h) 09120073930163, CNAP® double finger cuff "medium", sensor with Unlimited Lifecycle (600h) 09120073930200, CNAP® double finger cuff "small", sensor with Unlimited Lifecycle (600h) 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
CNSystems Medizintechnik AG
V1.4
Not in Commercial Distribution

  • 09120073931092 ()
21-FHCN-15514

  • Noninvasive haemodynamic monitoring system

CNAP® Monitor 500 - 09120073931085

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
CNSystems Medizintechnik AG
V1.4
Not in Commercial Distribution

  • 09120073931085 ()
21-FHCN-15513

  • Noninvasive haemodynamic monitoring system

CNAP® Monitor 500 - 09120073931078

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 09120073930125, CNAP® double finger cuff "large", sensor with Extended Lifecycle (150h) 09120073930163, CNAP® double finger cuff "medium", sensor with Extended Lifecycle (150h) 09120073930200, CNAP® double finger cuff "small", sensor with Extended Lifecycle (150h) 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
CNSystems Medizintechnik AG
V1.4
Not in Commercial Distribution

  • 09120073931078 ()
21-FHCN-15512

  • Noninvasive haemodynamic monitoring system

CNAP® Monitor 500 - 09120073931061

SET of: 09120073930934, CNAP® Monitor 500, Main Unit including quick Guide 09120073930958, CNAP® controller set, incl. 09120073930965 CNAP® Controller and 09120073930088 Fixture for CNAP® controller, adapter between 09120073930965 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 09120073930125, CNAP® double finger cuff "large", sensor with Unlimited Lifecycle (600h) 09120073930163, CNAP® double finger cuff "medium", sensor with Unlimited Lifecycle (600h) 09120073930200, CNAP® double finger cuff "small", sensor with Unlimited Lifecycle (600h) 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
CNSystems Medizintechnik AG
V1.4
Not in Commercial Distribution

  • 09120073931061 ()
21-FHCN-15514

  • Noninvasive haemodynamic monitoring system

CNAP® Monitor 500 - 09120073931054

SET of: 09120073930934, CNAP® Monitor 500, Main Unit including quick Guide 09120073930958, CNAP® controller set, incl. 09120073930965 CNAP® Controller and 09120073930088 Fixture for CNAP® controller, adapter between 09120073930965 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
CNSystems Medizintechnik AG
V1.4
Not in Commercial Distribution

  • 09120073931054 ()
21-FHCN-15513

  • Noninvasive haemodynamic monitoring system

CNAP® Monitor 500 - 09120073931047

SET of: 09120073930934, CNAP® Monitor 500, Main Unit including quick Guide 09120073930958, CNAP® controller set, incl. 09120073930965 CNAP® Controller and 09120073930088 Fixture for CNAP® controller, adapter between 09120073930965 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 09120073930125, CNAP® double finger cuff "large", sensor with Extended Lifecycle (150h) 09120073930163, CNAP® double finger cuff "medium", sensor with Extended Lifecycle (150h) 09120073930200, CNAP® double finger cuff "small", sensor with Extended Lifecycle (150h) 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
CNSystems Medizintechnik AG
V1.4
Not in Commercial Distribution

  • 09120073931047 ()
21-FHCN-15512

  • Noninvasive haemodynamic monitoring system

CNAP® Monitor 500 - 09120073930996

SET of: 09120073930934, CNAP® Monitor 500, Main Unit including quick Guide 09120073930958, CNAP® controller set, incl. 09120073930965 CNAP® Controller and 09120073930088 Fixture for CNAP® controller, adapter between 09120073930965 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) 09120073930026, 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
CNSystems Medizintechnik AG
V1.4
Not in Commercial Distribution

  • 09120073930996 ()
21-FHCN-15513

  • Noninvasive haemodynamic monitoring system
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