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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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Patient interface module for intravascular ultrasound catheters
Philips Image Guided Therapy Corporation
802143001-ROHS
In Commercial Distribution

  • 00845225012762 ()
802143001-ROHS

  • Cardiovascular ultrasound imaging system
The balloon is intended to be used in combination with Double Balloon Endoscopes to assist with insertion inside the upper or lower digestive tract. This product is not intended for use for any neonates, infants or children.
FUJIFILM CORPORATION
BS-2
In Commercial Distribution

  • 04547410331370 ()
  • 84547410331376 ()
  • 14547410331377 ()


  • Gastrointestinal/biliary dilation balloon catheter, non-medicated
The IR Thermometer is intended to be used as the intermittent measurement of human body temperature for people of all ages.
AVITA CORPORATION
NT1G
In Commercial Distribution

  • 04710953421468 ()
  • 04710953421475 ()


  • Infrared patient thermometer, ear
SET of: 09120073931146, CNAP® Monitor 500 HD, 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 09120073930361 CNAP® forearm fixing cuff 09120073930361, CNAP® forearm fixing cuff, for fixing 09120073930101 CNAP® Controller 09120073930095, CNAP® cable, 2.5m; interface 09120073930101 CNAP® controller to 09120073931146 CNAP® Monitor 500 HD 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 09120073930279, Operator's Manual GERMAN, 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 Standard, 20-HEKA-01015, 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

  • 09120073931139 ()
21-FHCN-15529

  • Noninvasive haemodynamic monitoring system
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
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
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
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
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
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
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