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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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PCS2, LIST NO. 06002-CP-220
HAEMONETICS CORPORATION
06002-CP-220
In Commercial Distribution

  • 30812747011826 ()


  • Autotransfusion system blood component processing set
Plasma Bottles with Saline Adapter
HAEMONETICS CORPORATION
0694S-00
In Commercial Distribution

  • 30812747011673 ()
  • 00812747011672 ()

  • Total Volume: 1000 Milliliter


  • Apheresis system tubing set
No Description
SCC SOFT COMPUTER
25.6.1.2
In Commercial Distribution

  • 00810055815647 ()


  • Blood bank information system application software
No Description
SCC SOFT COMPUTER
1.0.0.20
In Commercial Distribution

  • 00810055815302 ()


  • Bedside information system application software
No Description
SCC SOFT COMPUTER
25.5.6.4
In Commercial Distribution

  • 00810055814503 ()


  • Blood bank information system application software
No Description
SCC SOFT COMPUTER
4.5.5.1
In Commercial Distribution

  • 00810055814152 ()


  • Blood bank information system application software
No Description
SCC SOFT COMPUTER
1.0.0.19
In Commercial Distribution

  • 00810055814145 ()


  • Bedside information system application software
No Description
SCC SOFT COMPUTER
25.5.6.3
In Commercial Distribution

  • 00810055813667 ()


  • Blood bank information system application software
No Description
SCC SOFT COMPUTER
4.5.4.2
In Commercial Distribution

  • 00810055813650 ()


  • Blood bank information system application software
No Description
SCC SOFT COMPUTER
25.6.1.1
In Commercial Distribution

  • 00810055812837 ()


  • Blood bank information system application software
No Description
SCC SOFT COMPUTER
25.6.2.0
In Commercial Distribution

  • 00810142371827 ()


  • Blood bank information system application software
No Description
Citra Labs, LLC
PN-7212
In Commercial Distribution

  • 00887868260285 ()
  • 70887868260284 ()
PN-7212

  • Blood transfer set
3M™ Ranger® Fluid Warming Set, Standard Flow, 10 Per Case 24110
3M COMPANY
24110
In Commercial Distribution

  • 50608223241108 ()
  • 00608223241103 ()
24110

  • Conduction blood/fluid warmer set
Aurora Xi Plasmapheresis System with Software Version 2.0
Fresenius Kabi AG
Software Version 2.0
In Commercial Distribution

  • 00810020442199 ()


  • Apheresis system
For Extended Platelet Storage and Plasma Collection. For Platelet Storage in Plasma or Platelet Additive Solution Plus Plasma. For Use with the Amicus Separator.
Fresenius Kabi AG
4R2361
In Commercial Distribution

  • 10810020441649 ()
  • 00810020441642 ()
4R2361

  • Apheresis system tubing set
For Extended Platelet Storage with Plasma and Red Blood Cell Collection. For Platelet Storage in Plasma or Platelet Additive Solution Plus Plasma. For Use with the Amicus Separator.
Fresenius Kabi AG
4R2360
In Commercial Distribution

  • 10810020441632 ()
  • 00810020441635 ()
4R2360

  • Apheresis system tubing set
Software version for AMICUS Separator Legacy Device
Fresenius Kabi AG
6.1.51.0
In Commercial Distribution

  • 00810020441208 ()


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

  • 00810020441192 ()


  • Apheresis system
For Collection of Plasma by Membrane Filtration. For Use With the Aurora Xi Instrument. Sterile Fluid Path.
Fresenius Kabi AG
6R2600P
In Commercial Distribution

  • 10810020441113 ()
  • 00810020441116 ()
6R2600P

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

  • 00810020440898 ()


  • Apheresis system
For Extended Platelet Storage and Plasma Collection. For Platelet Storage in Plasma or Platelet Additive Solution Plus Plasma. For Use with the AMICUS Separator.
Fresenius Kabi AG
4R2359
In Commercial Distribution

  • 10810020440765 ()
  • 00810020440768 ()
4R2359

  • Apheresis system tubing set
For processing and/or storage of blood and blood components. Sterile Fluid Path.
Fresenius Kabi AG
6R2042
In Commercial Distribution

  • 10810020440666 ()
  • 00810020440669 ()
6R2042

  • Blood/tissue storage/culture container
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
For Extended Platelet Storage with Plasma and Red Blood Cell Collection. For Platelet Storage in Plasma or Platelet Additive Solution Plus Plasma. For Use with the AMICUS Separator.
Fresenius Kabi AG
4R2358
In Commercial Distribution

  • 10810020440277 ()
  • 00810020440270 ()
4R2358

  • 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
4R2353G
In Commercial Distribution

  • 10810020440161 ()
  • 00810020440164 ()
4R2353G

  • 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
4R2354G
In Commercial Distribution

  • 00810020440140 ()
  • 10810020440147 ()
4R2354G

  • Apheresis system tubing set
Aurora Plasmapheresis System Software Version 2.1
Fresenius Kabi AG
SW 2.1
In Commercial Distribution

  • 00810020440003 ()
  • 10810020440000 ()


  • Apheresis system
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