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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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ADAM-rWBC is a device to count white blood cell. It is used with ADAM-rWBC kit.
NanoEnTek, Inc.
ADAM-rWBC
In Commercial Distribution

  • 08809317540252 ()
ADAM-rWBC

  • White blood cell count IVD, kit, cell count
Device, Blood Mixing And Weighing
Fresenius Kabi AG
9029651
In Commercial Distribution

  • 04086000860758 ()
9029651

  • Blood donation rocker
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
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
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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