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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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No Description
FUJIREBIO INC.
230862
In Commercial Distribution

  • 04987270230862 ()

  • Size Type = Units per kit; Units = 6; Unit of Measure = 9.0mLs


  • Total testosterone IVD, calibrator
No Description
FUJIREBIO INC.
230190
Not in Commercial Distribution

  • 04987270230190 ()

  • Size Type = Tests per kit; Size Unit = 42; Unit of Measure = Tests


  • Parathyroid hormone (PTH) IVD, kit, chemiluminescent immunoassay
The POC-ASI10 Auto sampler expands the number of breath collection bags that can be set up and analyzed by the POCone Infrared Spectrophotometer.
OTSUKA ELECTRONICS CO.,LTD.
POC-AS10
In Commercial Distribution

  • 04987035388517 ()


  • Infrared spectrometry breath analyser IVD
The POCone Infrared Spectrophotometer is an in vitro diagnostic device designed to measure changes in 13CO2 content in breath CO2 gas by infrared spectroscopic analysis. The POCone Infrared Spectrophotometer is intended for use in conjunction with commercially available Meretek 13C-urea breath tests for the detection of Helicobacterpylori (H. pylon) infection. The POCone Infrared Spectrophotometer is suitable for use in both point of care and clinical laboratory settings.
OTSUKA ELECTRONICS CO.,LTD.
POCone
In Commercial Distribution

  • 04987035343417 ()


  • Infrared spectrometry breath analyser IVD
eUnity software is a diagnostic medical imaging display workstation. As part of an EMR, Portal or as a stand-alone application, eUnity provides secure access to full-fidelity DICOM images with unprecedented performance using nothing more than a common web-browser (no client software to manage.) Medical professionals can now access medical images across multiple sites and multiple PACS using eUnity as their image viewing platform.
Mach7 Technologies Canada Inc
eUnity-1
In Commercial Distribution

  • 00628914000017 ()


  • Radiological PACS software
MASK PEDIATRIC 3 IN1- 1 SIDE VALVE OXYGEN ADAPTER LOOSE 7' SAFLO TUBE
Canadian Hospital Specialties Limited
R-2755S
In Commercial Distribution

  • 50628725099809 ()
  • 00628725099804 ()
R-2755S

  • Rebreathing oxygen face mask
PEDIATRIC THREE-IN-ONE MASK
Canadian Hospital Specialties Limited
R-2655
In Commercial Distribution

  • 50628725099762 ()
  • 00628725099767 ()
R-2655

  • Rebreathing oxygen face mask
MASK ADULT NON REBREATHER OXYGEN ONE VALVE W/7' SAFLO OXYGEN
Canadian Hospital Specialties Limited
R-2450S
In Commercial Distribution

  • 50628725099700 ()
  • 00628725099705 ()
R-2450S

  • Rebreathing oxygen face mask
MASK ADULT NON REBREATHER ONE VALVE
Canadian Hospital Specialties Limited
R-2350
In Commercial Distribution

  • 50628725099670 ()
  • 00628725099675 ()
R-2350

  • Rebreathing oxygen face mask
MASK ADULT 3 IN 1 OXYGEN WITH 7' SAFLO OXYGEN TUBING MULTIFIT CONNECTOR
Canadian Hospital Specialties Limited
R-2255SM
In Commercial Distribution

  • 50628725099557 ()
  • 00628725099552 ()
R-2255SM

  • Rebreathing oxygen face mask
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