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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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Aurora Xi - 00810020440560

Aurora Xi Plasmapheresis System with Software Version 2.1
Fresenius Kabi AG
Software Version 2.1
In Commercial Distribution

  • 00810020440560 ()


  • Apheresis system

Aurora Software Version 2.1C Upgrade - 00810020440300

AURORA Software Version 2.1C for collection of plasma by membrane filtration.
Fresenius Kabi AG
Version 2.1C
In Commercial Distribution

  • 00810020440300 ()
  • 10810020440307 ()
X6S4021USB

  • Apheresis system

Aurora Plasmapheresis System Software Version 2.1 - 00810020440003

Aurora Plasmapheresis System Software Version 2.1
Fresenius Kabi AG
SW 2.1
In Commercial Distribution

  • 00810020440003 ()
  • 10810020440000 ()


  • Apheresis system

DonorCare® Needle Guard Large Channel - 19555240400151

DonorCare® Needle Guard is intended to aid in the prevention of accidental needle stick injuries upon completion of blood collection procedures.
ITL ASIA PACIFIC SDN. BHD.
A100150
In Commercial Distribution

  • 09555240400154 ()
  • 19555240400151 ()
A100150

  • Needle guard

DonorCare® Needle Guard Small Channel - 19555240400137

DonorCare Needle Guard is intended to aid in the prevention of accidental needle stick injuries upon completion of blood collection procedures.
ITL ASIA PACIFIC SDN. BHD.
A100100
In Commercial Distribution

  • 09555240400130 ()
  • 19555240400137 ()
A100100

  • Needle guard

Neg Control - 23661562105438

Negative control reagent for Anti-D Monoclonal Blood Grouping Reagents (210524-210525-210526) for manual tube technique
DIAGAST
210543
In Commercial Distribution

  • 23661562105438 ()
  • 13661562105431 ()
210543

  • Antisera matrix (non-reactive) IVD, control

StemTrol Control Cells - 15099590762896

StemTrol Control Cells
Beckman Coulter, Inc.
IM3632US
In Commercial Distribution

  • 15099590762896 ()
IM3632US

  • Fixative, Orth's solution
  • Multiple CD cell marker IVD, control

PXP - 00886368000650

PXP Docking Station
Thermogenesis Corp.
80066
In Commercial Distribution

  • 00886368000643 ()
  • 00886368000650 ()


  • Blood centrifugation system containment kit

PXP - 00886368000636

PXP Control Module
Thermogenesis Corp.
80065
In Commercial Distribution

  • 00886368000629 ()
  • 00886368000636 ()


  • Blood centrifugation system containment kit

AutoXpress Platform Counterbalance CG - 00886368000568

No Description
Thermogenesis Corp.
8-5144
In Commercial Distribution

  • 00886368000568 ()
8-5144

  • Cryobiological storage container
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