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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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ImmuLINK - 10888234002475

ImmuLINK is middleware software that allows the user to link the application software database on automated (and/or semi-automated) blood bank instruments; the user may also link the instrument database(s) with the user’s Laboratory Information System (LIS). ImmuLINK is software designed to provide an interface between the user, blood bank instruments, and Blood Establishment Computer. ImmuLINK allows integration of sample, donor, or patient data that has been collected from multiple sources and provides data management tools to create customizable reports from the diverse data.
IMMUCOR, INC.
0030311
In Commercial Distribution

  • 10888234002475 ()


  • Laboratory instrument/analyser application software IVD

Aurora Plasmapheresis System - 04086000100236

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

ALYX 2RBC LR KIT - 04086000100199

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

Aurora Xi Software - 04086000101516

Software version for Aurora Xi.
Fresenius Kabi AG
1.1
In Commercial Distribution

  • 04086000101516 ()


  • Apheresis system

Fenwal AMICUS Apheresis Kit - Single Needle Functionally Closed - 04086000100991

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

Fenwal AMICUS Apheresis Kit - Double Needle Functionally Closed - 04086000100984

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

Acrodose PLus System - 10887691310697

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

Trima Accel® - 05020583810020

Automated Blood Collection System
TERUMO BCT, INC.
81002
In Commercial Distribution

  • 05020583810020 ()


  • Apheresis system

TSCD® II - 05020583620018

Sterile Tubing Welder
TERUMO BCT, INC.
62001
In Commercial Distribution

  • 05020583620018 ()


  • Package sealing unit

Trima Accel® - 05020583810006

Automated Blood Collection System
TERUMO BCT, INC.
81000
In Commercial Distribution

  • 05020583810006 ()


  • Apheresis system
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