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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

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

Trima Accel® - 05020583810006

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

  • 05020583810006 ()


  • Apheresis system

TSCD®-II - 05020583620001

Terumo Sterile Tubing Welder
TERUMO BCT, INC.
62000
In Commercial Distribution

  • 05020583620001 ()


  • Package sealing unit

Vista ® - 05020583252035

Vista® Information System Version 4 Vista Standard Interface and SafeTrace® BBSI Installation Guide
TERUMO BCT, INC.
25203
In Commercial Distribution

  • 05020583252035 ()


  • Blood bank information system

Vista® - 05020583252028

Information System Version 4, Vista Standard Interface and SafeTrace® BBSI Installation Guide
TERUMO BCT, INC.
25202
In Commercial Distribution

  • 05020583252028 ()


  • Blood bank information system

Vista ® - 05020583252011

Vista Information System, Version 4.2
TERUMO BCT, INC.
25201
In Commercial Distribution

  • 05020583252011 ()


  • Blood bank information system

COBE® Spectra - 05020583704008

Single-Needle Extended Life Platelet Set With LRS® Chamber
TERUMO BCT, INC.
70400
Not in Commercial Distribution

  • 05020583704008 ()
  • 35020583704009 ()


  • Blood transfer set

TSCD® II - 05020583620018

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

  • 05020583620018 ()


  • Package sealing unit
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