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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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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

Aurora Software Version 1.3 Upgrade Kit - 04086000101059

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

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

AMICUS Apheresis Kit – Double Needle with Platelet Additive Solution Connector - 04086000100960

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

  • 14086000100967 ()
  • 04086000100960 ()
X6R2302

  • Apheresis system tubing set

AMICUS Apheresis Kit – Single Needle with Platelet Additive Solution Connector - 04086000100953

AMICUS Apheresis Kit – Single Needle with Platelet Additive Solution Connector
Fresenius Kabi AG
X6R2301
In Commercial Distribution

  • 14086000100950 ()
  • 04086000100953 ()
X6R2301

  • Apheresis system tubing set

ORTHO Daily QC Simulated Whole Blood Quality Control Kit - 04065266566086

No Description
MILLIPORE (U.K.) LIMITED
6708858
In Commercial Distribution

  • 04065266566086 ()
6708858

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

CompoGuard Complete (NA) - 04086000860765

Device, Blood Mixing and Weighing
Fresenius Kabi AG
9029661
In Commercial Distribution

  • 04086000860765 ()
9029661

  • Blood donation rocker

CompoGuard Basic (NA) - 04086000860741

Device, Blood Mixing And Weighing
Fresenius Kabi AG
9029641
In Commercial Distribution

  • 04086000860741 ()
9029641

  • Blood donation rocker
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