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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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CompoMat G5 Plus - 04086000860161

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 Data Management System - 04086000101578

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

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

Fenwal PLASMACELL-C Disposable Set For Use With SPIKESMART System - 04086000101356

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

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

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
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