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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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A discrete photometric chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes. Different models of the device incorporate various instrumentation such as micro analysis apparatus, double beam, single, or dual channel photometers, and bichromatic 2-wavelength photometers. Some models of the device may include reagent-containing components that may also serve as reaction units.
Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag
Pictus 400 clinical chemistry analyzer with barcode reader
In Commercial Distribution

  • 15999860094224 ()
  • 05999860094227 ()

  • Height: 630 Millimeter
  • Depth: 750 Millimeter
  • Width: 1050 Millimeter
P400-3

  • Multiple clinical chemistry analyser IVD, laboratory
A discrete photometric chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes. Different models of the device incorporate various instrumentation such as micro analysis apparatus, double beam, single, or dual channel photometers, and bichromatic 2-wavelength photometers. Some models of the device may include reagent-containing components that may also serve as reaction units.
Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag
P500 clinical chemistry analyzer with ISE open
In Commercial Distribution

  • 15999860094217 ()
  • 05999860094210 ()

  • Height: 820 Millimeter
  • Depth: 750 Millimeter
  • Width: 980 Millimeter
P500-2-o

  • Multiple clinical chemistry analyser IVD, laboratory
A discrete photometric chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes. Different models of the device incorporate various instrumentation such as micro analysis apparatus, double beam, single, or dual channel photometers, and bichromatic 2-wavelength photometers. Some models of the device may include reagent-containing components that may also serve as reaction units.
Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag
P500 clinical chemistry analyzer with ISE
In Commercial Distribution

  • 15999860094200 ()
  • 05999860094203 ()

  • Height: 820 Millimeter
  • Depth: 750 Millimeter
  • Width: 980 Millimeter
P500-2

  • Multiple clinical chemistry analyser IVD, laboratory
A discrete photometric chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes. Different models of the device incorporate various instrumentation such as micro analysis apparatus, double beam, single, or dual channel photometers, and bichromatic 2-wavelength photometers. Some models of the device may include reagent-containing components that may also serve as reaction units.
Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag
P500 clinical chemistry analyzer W/out ISE module open
In Commercial Distribution

  • 15999860094194 ()
  • 05999860094197 ()

  • Height: 820 Millimeter
  • Depth: 750 Millimeter
  • Width: 980 Millimeter
P500-1-o

  • Multiple clinical chemistry analyser IVD, laboratory
A discrete photometric chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes. Different models of the device incorporate various instrumentation such as micro analysis apparatus, double beam, single, or dual channel photometers, and bichromatic 2-wavelength photometers. Some models of the device may include reagent-containing components that may also serve as reaction units.
Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag
Pictus 700 clinilcal chemistry analyzer with ISE
In Commercial Distribution

  • 15999860094187 ()
  • 05999860094180 ()

  • Height: 1360 Millimeter
  • Depth: 840 Millimeter
  • Width: 1370 Millimeter
P700-3

  • Multiple clinical chemistry analyser IVD, laboratory
The Vasoview Hemopro 3 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, C-Ring, distal lens washer tube and Vasoview Hemopro 3 Harvesting Tool for cutting and cauterization of vessel branches. The C-Ring with the built-in distal lens washer is independently controlled by a C-Ring Slider on the handle of the Harvesting Cannula. The C-Ring cradles the vessel and delivers the saline that washes the distal tip of the Endoscope. The Harvesting Tool can be inserted, removed, rotated, extended, and retracted from the main Harvesting Cannula through the Tool Adapter Port. The Harvesting Tool is powered by direct current (DC) only; it does not utilize RF (radio frequency) energy. The Harvesting Tool cuts and cauterizes through a process of heat and pressure. The Harvesting Tool has two curved Jaws. One of the Jaws contains the heating elements for branch cutting and cauterization and spot cautery. There are three heating elements: two cauterization elements and a cutting element between them. Both Jaws have insulation protecting the adjacent tissue. The concave side of the Jaws has a larger buffer of insulation and therefore should be positioned toward sensitive tissue during Jaw activation. An area near the tip of the convex side of the Jaw can be used for spot cautery to cauterize tissue contacted by that area of the Jaw. The Activation Toggle is used to control the Jaws and to activate the heating elements. Positioning of the device, cutting, and cauterization are performed under endoscopic visualization. This device is intended for specific use with the Vasoview Hemopro Power Supply and Vasoview Hemopro 3 Power Adapter.
MAQUET CARDIOVASCULAR LLC
VH-6020
Not in Commercial Distribution

  • 00607567701298 ()
VH-6020

  • Flexible endoscopic scissors, reusable
MyeLyte Touch is discrete photometric clinical chemistry analyzer. The device is intended to duplicate manual analytical procedures by automating various steps such as pipetting, heating, measuring color intensity, and reporting results. The device is intended to be used with certain materials to measure various analytes of diagnostic interest including glucose. An optional Ion Selective Electrode Module is intended to measure sodium, potassium and chloride. MyeLyte Touch with glucose hexokinase assay are intended to measure glucose quantitatively in human serum. Additionally, MyeLyte Touch with Ion-Selective Elective modules additionally measure the concentration of the electrolytes, sodium, potassium and chloride in serum, using indirect potentiometry.
TOKYO BOEKI MEDISYS INC.
60-01-9003
In Commercial Distribution

  • 04580262049826 ()
60-01-9003

  • Multiple clinical chemistry analyser IVD, laboratory
DZ-Lite c270 is discrete photometric clinical chemistry analyzer. The device is intended to duplicate manual analytical procedures by automating various steps such as pipetting, heating, measuring color intensity, and reporting results. The device is intended to be used with certain materials to measure various analytes of diagnostic interest including glucose. An optional Ion Selective Electrode Module is intended to measure sodium, potassium and chloride. DZ-Lite c270 with glucose hexokinase assay are intended to measure glucose quantitatively in human serum. Additionally, DZ-Lite c270 with Ion-Selective Elective modules additionally measure the concentration of the electrolytes, sodium, potassium and chloride in serum, using indirect potentiometry.
TOKYO BOEKI MEDISYS INC.
60-01-9002
In Commercial Distribution

  • 04580262049819 ()
60-01-9002

  • Multiple clinical chemistry analyser IVD, laboratory
IMMTOX 270 is discrete photometric clinical chemistry analyzer. The device is intended to duplicate manual analytical procedures by automating various steps such as pipetting, heating, measuring color intensity, and reporting results. The device is intended to be used with certain materials to measure various analytes of diagnostic interest including glucose. An optional Ion Selective Electrode Module is intended to measure sodium, potassium and chloride. IMMTOX 270 with glucose hexokinase assay are intended to measure glucose quantitatively in human serum. Additionally, IMMTOX 270 with Ion-Selective Elective modules additionally measure the concentration of the electrolytes, sodium, potassium and chloride in serum, using indirect potentiometry.
TOKYO BOEKI MEDISYS INC.
60-01-9001
In Commercial Distribution

  • 04580262049802 ()
60-01-9001

  • Multiple clinical chemistry analyser IVD, laboratory
BIOLIS 30i is discrete photometric clinical chemistry analyzer. The device is intended to duplicate manual analytical procedures by automating various steps such as pipetting, heating, measuring color intensity, and reporting results. The device is intended to be used with certain materials to measure various analytes of diagnostic interest including glucose. An optional Ion Selective Electrode Module is intended to measure sodium, potassium and chloride. BIOLIS 30i with glucose hexokinase assay are intended to measure glucose quantitatively in human serum. Additionally, BIOLIS 30i with Ion-Selective Elective modules additionally measure the concentration of the electrolytes, sodium, potassium and chloride in serum, using indirect potentiometry.
TOKYO BOEKI MEDISYS INC.
60-01-0001
In Commercial Distribution

  • 04580262016002 ()
60-01-0001

  • Multiple clinical chemistry analyser IVD, laboratory
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