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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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For Collection of Platelets with Optional Plasma. For Platelet Storage in Plasma or Platelet Additive Solution Plus Plasma. For Use with the AMICUS Separator. Sterile Fluid Path.
Fresenius Kabi AG
4R2354G
In Commercial Distribution

  • 00810020440140 ()
  • 10810020440147 ()
4R2354G

  • Apheresis system tubing set
Aurora Plasmapheresis System Software Version 2.1
Fresenius Kabi AG
SW 2.1
In Commercial Distribution

  • 00810020440003 ()
  • 10810020440000 ()


  • Apheresis system
No Description
ALMA LASERS LTD.
1
In Commercial Distribution

  • 07290110123055 ()
AAVF16042301

  • Liposuction system
StemTrol Control Cells
Beckman Coulter, Inc.
IM3632
In Commercial Distribution

  • 15099590220020 ()
IM3632

  • Fixative, Orth's solution
StemComp Reagent
Beckman Coulter, Inc.
IM3631
In Commercial Distribution

  • 15099590220013 ()
IM3631

  • Fixative, Orth's solution
Leuko-Trol Platelet Control Cells
Beckman Coulter, Inc.
PLT Control
In Commercial Distribution

  • 15099590639402 ()
175651

  • Full blood count IVD, control
Leuko-Trol RBC Control Cells
Beckman Coulter, Inc.
RBC Control
In Commercial Distribution

  • 15099590639396 ()
175658

  • Full blood count IVD, control
stemONE
Beckman Coulter, Inc.
6915452
In Commercial Distribution

  • 15099590559519 ()
6915452

  • Laboratory instrument/analyser application software IVD
StemTrol Control Cells
Beckman Coulter, Inc.
IM3632US
In Commercial Distribution

  • 15099590762896 ()
IM3632US

  • Fixative, Orth's solution
  • Multiple CD cell marker IVD, control
PXP Disposable Cartridge
Thermogenesis Corp.
80088
In Commercial Distribution

  • 00886368000155 ()
  • 00886368001015 ()


  • Blood centrifugation system containment kit
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