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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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The CompoMat G5 / CompoMaster Net G5 System is intended as an automated blood component separator used for blood component separation and preparation.
Fresenius Kabi AG
9025571
In Commercial Distribution

  • 04086000860581 ()
9025571

  • Blood component separator, automated
The CompoDock is used for the production of special cellular blood components, e.g. in blood banks where tube connections are needed that provide protection against microbial contamination. The CompoDock is a high-frequency connection device that permits sterile connection of medical PVC tubes to one another. Here, sterile connection is achieved when germs from the environment are prevented from being carried into the closed systems. The closed system is maintained after the docking process.
Fresenius Kabi AG
9028721
In Commercial Distribution

  • 04086000860215 ()
9028721

  • Laboratory tubing welder
The CompoMat G5/ CompoMat G5 Plus/ CompoMaster Net G5 Plus system is intended to be used as an automatic blood component separator for blood component separation and processing.
Fresenius Kabi AG
9026561
In Commercial Distribution

  • 04086000860161 ()
9026561

  • Blood component separator, automated
DXT is intended to be used in blood establishments to facilitate networked communication between DXT compatible Fresenius Kabi apheresis devices and BECS or other Data Management Systems.
Fresenius Kabi AG
3.0
In Commercial Distribution

  • 04086000101578 ()
X6S9830, X6S9830USB

  • Blood bank information system application software
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
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
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
For Collection of Virtually Cell Free Plasma by Membrane Filtration. For Use with the AURORA Instrument or the AUTOPHERESIS-C Instrument. Sterile Fluid Path.
Fresenius Kabi AG
4R2256
In Commercial Distribution

  • 04086000101356 ()
  • 14086000101353 ()
4R2256

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

  • 14086000100950 ()
  • 04086000100953 ()
X6R2301

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

  • 04086000860765 ()
9029661

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

  • 04086000860741 ()
9029641

  • Blood donation rocker
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