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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
HELENA LABORATORIES CORPORATION
1800000
In Commercial Distribution

  • M52518000000 ()


  • Electrophoresis analyser IVD
No Description
HELENA LABORATORIES CORPORATION
1258
In Commercial Distribution

  • M52512580 ()


  • Protein electrophoresis IVD, kit, electrophoresis
No Description
THE BINDING SITE GROUP LIMITED
XK003
Not in Commercial Distribution

  • 05051700011235 ()


  • Protein electrophoresis IVD, kit, electrophoresis
No Description
THE BINDING SITE GROUP LIMITED
XK001
Not in Commercial Distribution

  • 05051700011211 ()


  • Protein electrophoresis IVD, kit, electrophoresis
No Description
THE BINDING SITE GROUP LIMITED
RN012.3
Not in Commercial Distribution

  • 05051700010467 ()


  • Total immunoglobulin M (IgM total) IVD, kit, precipitation/immunodiffusion
No Description
THE BINDING SITE GROUP LIMITED
RN010.3
Not in Commercial Distribution

  • 05051700010450 ()


  • Total immunoglobulin A (IgA total) IVD, kit, precipitation/immunodiffusion
Immunoglobulin M Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10444984
In Commercial Distribution

  • 00842768005732 ()
  • 00630414004600 ()
DF81

  • Immunoglobulin M subclass (IgM subclass) IVD, kit, nephelometry/turbidimetry
Immunoglobulin A Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10444982
In Commercial Distribution

  • 00842768005688 ()
  • 00630414004587 ()
DF74

  • Immunoglobulin A subclass (IgA subclass) IVD, kit, nephelometry/turbidimetry
The VersaPump Infuser is a reusable mechanical, non-electronic infusion pump that does not require batteries or any electrical source. There are no alarms or displays. The VersaPump Infuser uses a spring as a source of energy to provide pressure for the subcutaneous infusion of the indicated human plasma-derived immunoglobulin solutions. The VersaPump Infuser is provided with a carrying case and User Manual. The carrying case allows the user to strap the VersaPump to their shoulder and walk around their environment during an infusion cycle. The VersaPump enclosure is made of synthetic polymer blend of glass reinforced polyphenylene ether and polystyrene, the spring is a 301 stainless steel spring, and the spring enclosure is made of synthetic polymer polyoxymethylene (POM/acetal).
EMED TECHNOLOGIES CORPORATION
FP-0010209
In Commercial Distribution

  • 00817708023404 ()
FP-0010209

  • Ambulatory non-insulin infusion pump, mechanical, reusable
SCIg60 Infusion Pump Carrying Case
EMED TECHNOLOGIES CORPORATION
FP-0010032
In Commercial Distribution

  • 00817708023398 ()


  • Ambulatory non-insulin infusion pump, mechanical, reusable
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