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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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Software version for AMICUS Separator Life Extension Device
Fresenius Kabi AG
6.1.122.0
In Commercial Distribution

  • 00810020441192 ()


  • Apheresis system
Software Version 1.3 for Aurora Xi
Fresenius Kabi AG
1.3
In Commercial Distribution

  • 00810020440898 ()


  • Apheresis system
Software version for AMICUS Separator Life Extension Device
Fresenius Kabi AG
6.1.113.0
In Commercial Distribution

  • 00810020440607 ()


  • Apheresis system
Software version for AMICUS Separator Legacy Device
Fresenius Kabi AG
6.1.13.0
In Commercial Distribution

  • 00810020440591 ()


  • Apheresis system
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 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
Fresenius Kabi AG
SW 2.1
In Commercial Distribution

  • 00810020440003 ()
  • 10810020440000 ()


  • Apheresis system
Leukocyte Reduction Filter System for Red Blood Cells with BPF4 High Efficiency Filter, 16-Segment Tubing, Storage Bag and Sample Pouch
HAEMONETICS CORPORATION
430-40
In Commercial Distribution

  • 30887691308742 ()
  • 20887691308745 ()


  • Blood transfusion filter
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
Sterile Tube Welder
Wuhan BMS Medicaltech Co., Ltd
STW6810-RFID
In Commercial Distribution

  • 06976052440092 ()


  • Laboratory tubing welder
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