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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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Amicus MNC Apheresis Kit - Double Needle - 04086000100144

For Mononuclear Cell (MNC) Collection. For use with the AMICUS separator. Sterile Fluid Path.
Fresenius Kabi AG
X6R2326
In Commercial Distribution

  • 04086000100144 ()
  • 14086000100141 ()
X6R2326

  • Apheresis system tubing set

Fenwal PLASMACELL-C Disposable Set - 04086000101455

For Collection of Plasma by Membrane Filtration. For Use with the AUTOPHERESIS-C Instrument. Sterile Fluid Path.
Fresenius Kabi AG
4R2252
In Commercial Distribution

  • 04086000101455 ()
  • 14086000101452 ()
4R2252

  • Apheresis system tubing set

Fenwal AMICUS Double Needle Advanced Kit - 04086000101387

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
4R2354
In Commercial Distribution

  • 14086000101384 ()
  • 04086000101387 ()
4R2354

  • Apheresis system tubing set

Fenwal AMICUS Single Needle Advanced Kit - 04086000101370

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

Glycerolyte 57 Solution - 04086000101288

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

Glycerolyte 57 Solution - 04086000101271

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

PLASMACELL Xi Disposable Set with SPIKESMART - 04086000101097

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

ALYX 2RBC-LR Kit with Saline Spike - 04086000101035

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

ALYX Plasma Kit - 04086000101028

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

ALYX RBC/PLASMA KIT - 04086000101004

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
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