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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 and/or Red Blood Cells. For Platelet Storage in Plasma or Platelet Additive Solution Plus Plasma. For Use with the AMICUS Separator. Sterile Fluid Path.
Fresenius Kabi AG
4R2353
In Commercial Distribution

  • 14086000101377 ()
  • 04086000101370 ()
4R2353

  • Apheresis system tubing set
500 ML. Cryopreservative processing solution for manufacture of Red Blood Cells, Frozen. Not for intravenous infusion.
Fresenius Kabi AG
4A7833
In Commercial Distribution

  • 04086000101288 ()
  • 14086000101285 ()
4A7833

  • Blood storage solution, freezing
400 ML. Cryopreservative processing solution for manufacture of Red Blood Cells, Frozen. Not for intravenous infusion.
Fresenius Kabi AG
4A7831
In Commercial Distribution

  • 04086000101271 ()
  • 14086000101278 ()
4A7831

  • Blood storage solution, freezing
For Collection of Plasma by Membrane Filtration. For Use With the Aurora Xi Instrument. Sterile Fluid Path.
Fresenius Kabi AG
6R2600
In Commercial Distribution

  • 04086000101097 ()
  • 14086000101094 ()
6R2600

  • Apheresis system tubing set
A software upgrade package (accessory) to the Aurora Plasmapheresis System (primary device). For collection of plasma by membrane filtration.
Fresenius Kabi AG
6R2013
In Commercial Distribution

  • 04086000101059 ()
  • 14086000101056 ()
6R2013

  • Apheresis system
For Collection of Two Leukoreduced Red Blood Cell Products by Centrifugation. For Use with the ALYX System. Sterile fluid path.
Fresenius Kabi AG
4R5742
In Commercial Distribution

  • 14086000101032 ()
  • 04086000101035 ()
  • 00811137012992 ()
4R5742

  • Apheresis system tubing set
For Collection of Plasma Product by Centrifugation. For Use With the ALYX System. Sterile Fluid Path.
Fresenius Kabi AG
4R5730
In Commercial Distribution

  • 04086000101028 ()
  • 14086000101025 ()
4R5730

  • Apheresis system tubing set
For Collection of One Leukoreduced Red Blood Cell Product and Concurrent Plasma Product by Centrifugation. For Use with the ALYX System. Sterile Fluid Path.
Fresenius Kabi AG
X4R5700
In Commercial Distribution

  • 04086000101004 ()
  • 14086000101001 ()
X4R5700

  • Apheresis system tubing set
AMICUS Apheresis Kit – Double Needle with Platelet Additive Solution Connector
Fresenius Kabi AG
X6R2302
In Commercial Distribution

  • 14086000100967 ()
  • 04086000100960 ()
X6R2302

  • Apheresis system tubing set
No Description
MILLIPORE (U.K.) LIMITED
6708858
In Commercial Distribution

  • 04065266566086 ()
6708858

  • Non-blood cell primer/calibrator/control material IVD, reagent
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