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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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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
BIOLIS 50i Superior 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 50i Superior with glucose hexokinase assay are intended to measure glucose quantitatively in human serum. Additionally, BIOLIS 50i Superior 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.
50-01-0000
Not in Commercial Distribution

  • 04580262040014 ()
50-01-0000

  • Multiple clinical chemistry analyser IVD, laboratory
Biolis 24i Premium 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 24i Premium with glucose hexokinase assay are intended to measure glucose quantitatively in human serum. Additionally, Biolis 24i Premium 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.
23-01-0000
Not in Commercial Distribution

  • 04580262020016 ()
23-01-0000

  • Multiple clinical chemistry analyser IVD, laboratory
The Knee Restraint Strap Set has broad pads on the straps that safely prevent the knee from flexing during surgery and feature a full-length Velcro closure for a snug fit.
STERIS CORPORATION
BF552
In Commercial Distribution

  • 00724995182380 ()
BF552

  • Limb/torso/head restraint, reusable
The Armboard Multi Axis Pads are used with multi ais armboard.
STERIS CORPORATION
Table Pad
In Commercial Distribution

  • 00724995171537 ()
BF00029

  • Operating table mattress, basic
The 4-inch Cone-Shaped Headrest Pads are used on cone-shaped headrests.
STERIS CORPORATION
Table Pad
In Commercial Distribution

  • 00724995171483 ()
BF831

  • Multifunction body cushion
SKIN PREP TRAY 08
Cardinal Health 200, LLC
39-0110C
In Commercial Distribution

  • 50195594125873 ()
  • 10195594125875 ()
39-0110C

  • Surgical patient preparation kit
The Foot Traction Boot Pads with Straps, Adult is used with the TenZor Carbon Fiber Traction Unit Assembly.
STERIS CORPORATION
BF538
In Commercial Distribution

  • 00724995165376 ()
BF538

  • Traction boot
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