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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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The FIBRINET® System is designed to be used for the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a small sample of blood at the patient point of care. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics. The 45 mL FIBRINET® System is available as a single pack (item number 510359) or as a multipack of 5 individually packaged kits (item number 510359-5). The 45 mL FIBRINET® System contains 5 blood collection tubes with yellow stoppers containing buffered sodium citrate solution anticoagulant and plasma separator gel for preparing PRP, 1 PRFM tube containing calcium chloride solution with red stopper, two 30 mL membrane vials with closure containing calcium chloride solution, 1 latex free disposable tourniquet, 2 BD Vacutainer® Luer-Lok™ access devices, 1 BD Vacutainer® blood collection set with Safety-Lok® needle and 12" tubing preassembled, 2 BD Vacutainer® Blood transfer devices, and 1 vial adapter.
VERTICAL SPINE, LLC
510359
In Commercial Distribution

  • 30851802007060 ()
  • 10851802007066 ()

  • Total Volume: 45 Milliliter
510359

  • Haematological concentrate system preparation kit, platelet concentration
RBC DE-GLYCEROL./CELL WASH SET
HAEMONETICS CORPORATION
00235-00
In Commercial Distribution

  • 30812747015015 ()
  • 10812747015011 ()

  • Total Volume: 225 Milliliter
  • Total Volume: 5 Liter
  • Total Volume: 600 Milliliter


  • Blood cell freeze/thaw system set
RBC GLYCEROLIZATION SET
HAEMONETICS CORPORATION
00225-00
In Commercial Distribution

  • 30812747015008 ()
  • 10812747015004 ()


  • Blood cell freeze/thaw system set
Platelet Pool and Store Set with In-line Leukocyte Redcution Filter
HAEMONETICS CORPORATION
732-83
In Commercial Distribution

  • 30887691310691 ()
  • 10887691310697 ()


  • Blood/tissue storage/culture container
Software version for Aurora Xi.
Fresenius Kabi AG
1.1
In Commercial Distribution

  • 04086000101516 ()


  • Apheresis system
For Extended Platelet Storage with Plasma and Red Blood Cell Collection. For Use with the AMICUS Separator. Sterile Fluid Path.
Fresenius Kabi AG
4R2367
In Commercial Distribution

  • 14086000100998 ()
  • 04086000100991 ()
4R2367

  • Apheresis system tubing set
For Extended Platelet Storage and Plasma Collection. For Use with the AMICUS Separator. Sterile Fluid Path.
Fresenius Kabi AG
4R2365
In Commercial Distribution

  • 04086000100984 ()
  • 14086000100981 ()
4R2365

  • Apheresis system tubing set
Automated plasmapheresis system designed to collect virtually cell-free plasma by membrane filtration using single-use disposable sets. Collected plasma is to be processed as Source Plasma.
Fresenius Kabi AG
6R4601
In Commercial Distribution

  • 04086000100236 ()
6R4601

  • Apheresis system
For Collection of Two Leukoreduced Red Blood Cell Products by Centrifugation. For Use With the ALYX System. Sterile Fluid Path.
Fresenius Kabi AG
X4R5720
In Commercial Distribution

  • 04086000100199 ()
  • 14086000100196 ()
X4R5720

  • Apheresis system tubing set
For Collection of Two Leukoreduced Red Blood Cell Products by Centrifugation. For Use With the ALYX™ System. Sterile Fluid Path.
FENWAL, INC.
4R5720
In Commercial Distribution

  • 10811137010124 ()
  • 00811137010127 ()
4R5720

  • Apheresis system tubing set
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