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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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FDR D-EVO G43i - 04547410235968

The DR-ID 600SE, DR-ID 601SE and DR-ID 602SE incorporate a GOS indirect panel. The DR-ID 611SE, DR-ID 612SE and DR-ID 613SE incorporate a CsI indirect panel. There are six types of flat panel sensors: DR-ID 601SE, DR-ID 602SE, DR-ID 611SE, DR-ID 612SE and DR-ID 613SE (wireless/wired communication mode) and DR-ID 600SE (wired communication mode).
FUJIFILM CORPORATION
DR-ID 602 SE A E
In Commercial Distribution

  • 04547410235968 ()

  • 460x460x15.4mm


  • Stationary basic diagnostic x-ray system, digital

FDR D-EVO G35s - 04547410235951

The DR-ID 600SE, DR-ID 601SE and DR-ID 602SE incorporate a GOS indirect panel. The DR-ID 611SE, DR-ID 612SE and DR-ID 613SE incorporate a CsI indirect panel. There are six types of flat panel sensors: DR-ID 601SE, DR-ID 602SE, DR-ID 611SE, DR-ID 612SE and DR-ID 613SE (wireless/wired communication mode) and DR-ID 600SE (wired communication mode).
FUJIFILM CORPORATION
DR-ID 601 SE WIRED A E
In Commercial Distribution

  • 04547410235951 ()

  • 460x384x14.8mm


  • Stationary basic diagnostic x-ray system, digital

FDR D-EVO G35i - 04547410235944

The DR-ID 600SE, DR-ID 601SE and DR-ID 602SE incorporate a GOS indirect panel. The DR-ID 611SE, DR-ID 612SE and DR-ID 613SE incorporate a CsI indirect panel. There are six types of flat panel sensors: DR-ID 601SE, DR-ID 602SE, DR-ID 611SE, DR-ID 612SE and DR-ID 613SE (wireless/wired communication mode) and DR-ID 600SE (wired communication mode).
FUJIFILM CORPORATION
DR-ID 601 SE A E
In Commercial Distribution

  • 04547410235944 ()

  • 460x384x14.8mm


  • Stationary basic diagnostic x-ray system, digital

DR-ID 600MC - 04547410235937

A personal computer used for controlling the flat panel sensor and performing image processing.
FUJIFILM CORPORATION
DR-ID 601 MC-WITHOUT SOFT E
In Commercial Distribution

  • 04547410235937 ()


  • Stationary basic diagnostic x-ray system, digital

Cradle - 04547410235920

The Cradle for 24 is used for storing the flat panel sensor in a standing position. By using in combination with the CALNEO C power supply unit or the AC adapter for cradle (optional), the battery pack for the fl at panel sensor inserted into the Cradle for 24 can be charged. In addition, when the Cradle for 24 is connected to the CALNEO C power supply unit, the wireless communication setting can be switched.
FUJIFILM CORPORATION
DR613 STAND E
In Commercial Distribution

  • 04547410235920 ()


  • Stationary basic diagnostic x-ray system, digital

FUJIFILM - 04547410228090

This product is designed to attach a rubber band for fixing a balloon attached to a double-balloon endoscope at medical facilities under management of physiciants. Never use this product for any other purpose. Do not use this product to attach a balloon to the endoscope.
FUJIFILM CORPORATION
ST-10
In Commercial Distribution

  • 04547410228090 ()


  • Endoscope balloon positioner, reusable

FDR D-EVO plus C24s - 04547410225587

The DR-ID 600SE, DR-ID 601SE and DR-ID 602SE incorporate a GOS indirect panel. The DR-ID 611SE, DR-ID 612SE and DR-ID 613SE incorporate a CsI indirect panel. There are six types of flat panel sensors: DR-ID 601SE, DR-ID 602SE, DR-ID 611SE, DR-ID 612SE and DR-ID 613SE (wireless/wired communication mode) and DR-ID 600SE (wired communication mode).
FUJIFILM CORPORATION
DR-ID 613 SE WIRED E
In Commercial Distribution

  • 04547410225587 ()

  • 328x268x15.7mm


  • Stationary basic diagnostic x-ray system, digital

FCR ClearView CS Plus - 04547410220667

The FUJI Computed Radiography System FCR ClearView CS Plus/CSm Plus performs Digital Radiography by using an Imaging Plate (IP) as the X-ray detection device.
FUJIFILM CORPORATION
CR-IR 363
In Commercial Distribution

  • 04547410220667 ()


  • Computed radiography digital imaging scanner

FCR XG5000 Plus - 04547410220629

The FUJI Computed Radiography System FCR XG 5000 Plus performs Digital Radiography by using an Imaging Plate (IP) as the X-ray detection device.
FUJIFILM CORPORATION
CR-IR 362
In Commercial Distribution

  • 04547410220629 ()


  • Computed radiography digital imaging scanner

FCR ClearView CS Plus - 04547410220575

The FUJI Computed Radiography System FCR ClearView CS Plus/CSm Plus performs Digital Radiography by using an Imaging Plate (IP) as the X-ray detection device.
FUJIFILM CORPORATION
CR-IR 363
In Commercial Distribution

  • 04547410220575 ()


  • Computed radiography digital imaging scanner

Cradle - 04547410180282

The Cradle is used for storing the fl at panel sensor in a standing position. By using in combination with the CALNEO C power supply unit or the AC adapter for cradle (optional), the battery pack for the fl at panel sensor inserted into the Cradle can be charged. In addition, when the Cradle is connected to the CALNEO C power supply unit, the wireless communication setting can be switched.
FUJIFILM CORPORATION
DR600 STAND E
In Commercial Distribution

  • 04547410180282 ()


  • Stationary basic diagnostic x-ray system, digital

Li-ion Battery charger - 04547410180220

A battery charger for the battery pack. Three packs can be charged at the same time.
FUJIFILM CORPORATION
DR601 SE BATTERY CHARGER E
In Commercial Distribution

  • 04547410180220 ()


  • Stationary basic diagnostic x-ray system, digital

FUJIFILM - 04547410111903

This product is the cleaning adapter used in combination with our endoscopes in medical facilities. Do not use this product for any other purpose.
FUJIFILM CORPORATION
CA-501FJ/A
In Commercial Distribution

  • 24547410111907 ()
  • 04547410111903 ()


  • Luminal device flushing tubing set, reusable

FUJIFILM - 04547410111897

This product is the cleaning adapter used in combination with our endoscopes in medical facilities. Do not use this product for any other purpose.
FUJIFILM CORPORATION
CA-500D/A
In Commercial Distribution

  • 24547410111891 ()
  • 04547410111897 ()


  • Luminal device flushing tubing set, reusable

FUJIFILM - 04547410079180

This product is the balloon setting tool used in combination with our endoscope and balloon in medical facilities. Do not use this product for any other purpose.
FUJIFILM CORPORATION
ST-05B
In Commercial Distribution

  • 24547410079184 ()
  • 04547410079180 ()
  • 84547410079186 ()


  • Endoscope balloon positioner, single-use

FUJIFILM - 04547410079166

This product is the balloon attachment tool uesd in combination with our endoscopes in medical facilities. Do not use this product for any other purpose.
FUJIFILM CORPORATION
BA-1
In Commercial Distribution

  • 34547410079167 ()
  • 04547410079166 ()


  • Endoscope balloon positioner, reusable

FUJIFILM - 04547410079111

This product is intended to assist in the manual cleaning of accessible channels found in certain Fujinon/Fujifilm endoscopes in medical facilities. Do not use this product for any other purpose.
FUJIFILM CORPORATION
WB11001FW2
In Commercial Distribution

  • 34547410079112 ()
  • 04547410079111 ()
  • 44547410079119 ()


  • Surgical instrument/endoscope cleaning utensil, reusable

FUJIFILM - 04547410079074

This product is intended to assist in the manual cleaning of accessible channels found in certain Fujinon/Fujifilm endoscopes in medical facilities. Do not use this product for any other purpose.
FUJIFILM CORPORATION
WB3512FW
In Commercial Distribution

  • 04547410079074 ()
  • 34547410079075 ()
  • 44547410079072 ()


  • Flexible video bronchoscope, reusable

FUJIFILM - 04547410079067

This product is intended to assist in the manual cleaning of accessible channels found in certain Fujinon/Fujifilm endoscopes in medical facilities. Do not use this product for any other purpose.
FUJIFILM CORPORATION
WB3503FW
In Commercial Distribution

  • 04547410079067 ()
  • 34547410079068 ()
  • 44547410079065 ()


  • Flexible video bronchoscope, reusable

FUJIFILM - 04547410079036

This product is intended to assist in the manual cleaning of accessible channels found in certain Fujinon/Fujifilm endoscopes in medical facilities. Do not use this product for any other purpose.
FUJIFILM CORPORATION
WB3212FW2
In Commercial Distribution

  • 04547410079036 ()
  • 34547410079037 ()
  • 44547410079034 ()


  • Flexible video bronchoscope, reusable

FUJIFILM - 04547410079012

This product is intended to assist in the manual cleaning of accessible channels found in certain Fujinon/Fujifilm endoscopes in medical facilities. Do not use this product for any other purpose.
FUJIFILM CORPORATION
WB2221FW2
In Commercial Distribution

  • 34547410079013 ()
  • 04547410079012 ()
  • 44547410079010 ()


  • Surgical instrument/endoscope cleaning utensil, reusable

TekCare Non-Contact Infrared Thermometer - 04710953421598

The NT19 thermometer is designed for the intermittent measurement of the human body's temperature in the domestic environment and can be used upon people of all ages
AVITA CORPORATION
NT19
In Commercial Distribution

  • 04710953421604 ()
  • 04710953421598 ()


  • Infrared patient thermometer, ear

TekCare Touch Free Infrared Thermometer - 04710953421512

The NT17 THERMO DISTANCE thermometer is designed for the intermittent measurement of the human body's temperature in the domestic environment and can be used upon people of all ages
AVITA CORPORATION
NT17
In Commercial Distribution

  • 04710953421529 ()
  • 04710953421512 ()


  • Infrared patient thermometer, ear

TekCare Blood Pressure Monitor - 04710953421338

BPM19 Series Blood Pressure Monitor applies the Oscillometric method to measure human systolic / diastolic blood pressure and heart rate. All values are shown on the LCD monitor. This device is designed only for adults.
AVITA CORPORATION
BPM19
In Commercial Distribution

  • 04710953421345 ()
  • 04710953421338 ()


  • Automatic-inflation electronic sphygmomanometer, non-portable

TekCare Infrared Thermometer - 04710953421314

The device is an infrared thermometer intended for the intermittent measurement of human body temperature in people of all ages.
AVITA CORPORATION
TS46
In Commercial Distribution

  • 04710953421321 ()
  • 04710953421314 ()


  • Infrared patient thermometer, ear

TekCare Touch Free Infrared Thermometer - 04710953421291

The NT11 THERMO DISTANCE thermometer is designed for the intermittent measurement of the human body's temperature in a domestic environment, and can be used upon people of all ages.
AVITA CORPORATION
NT11
In Commercial Distribution

  • 04710953421307 ()
  • 04710953421291 ()


  • Infrared patient thermometer, ear

Blood pressure monitor - 04710953421161

The device is a arm type blood pressure monitor intended for automatically measures systolic and diastolic blood pressure and pulse rate by the oscillometric method. The measurement position is at the arm.The cuff circumference is limited to 220 mm - 420 mm (approx.:9 - 17 inches).The device is intended for home use. When the device detects irregular heart beats during measurement, an irregular heartbeat symbol will appear along with the measured readings
AVITA CORPORATION
BPA-O300
In Commercial Distribution

  • 04710953421161 ()
  • 04710953421192 ()


  • Automatic-inflation electronic sphygmomanometer, non-portable

Blood pressure monitor - 04710953420942

The device is a wrist type blood pressure monitor intended for automatically measures systolic and diastolic blood pressure and pulse rate by the oscillometric method. The measurement position is at the wrist. The device is intended to be used by adults with a wrist circumference ranging from 125mm to 210mm (approx. 4.9 to 8.3 inches). The device is intended for home use. When the device detects irregular heartbeats during measurement, an irregular heartbeat symbol will appear along with the measured readings.
AVITA CORPORATION
62220
In Commercial Distribution

  • 04710953420942 ()


  • Automatic-inflation electronic sphygmomanometer, non-portable

CNAP® Monitor 500 HD - 09120073933027

Main Unit;
CNSystems Medizintechnik GmbH
V1.5
In Commercial Distribution

  • 09120073933027 ()
21-FHCN-15544

  • Patient monitoring system module, blood pressure, noninvasive

CNAP® Monitor 500 HD - 09120073932990

Main Unit;
CNSystems Medizintechnik GmbH
V1.5
In Commercial Distribution

  • 09120073932990 ()
21-FHCN-15544

  • Patient monitoring system module, blood pressure, noninvasive
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