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

  • 05020583810006 ()


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

  • 05020583704008 ()
  • 35020583704009 ()


  • Blood transfer set
Sterile Tubing Welder
TERUMO BCT, INC.
62001
In Commercial Distribution

  • 05020583620018 ()


  • Package sealing unit
Terumo Sterile Tubing Welder
TERUMO BCT, INC.
62000
In Commercial Distribution

  • 05020583620001 ()


  • Package sealing unit
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
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 Information System, Version 4.2
TERUMO BCT, INC.
25201
In Commercial Distribution

  • 05020583252011 ()


  • Blood bank information system
ADAM-rWBC System is composted ADAM-rWBC(equipment) and ADAM-rWBC kit (reagent). This system is intended to be used for the qualitative determination of the residual white blood cell (leukocyte) count in human specimen.
NanoEnTek, Inc.
ADAM-rWBC System
In Commercial Distribution

  • 08809317540276 ()
ADAM-rWBC System

  • White blood cell count IVD, kit, cell count
It is used for the quantitative determination of the residual white blood cell (leukocyte) count in a human specimen using ADAM-rWBC.
NanoEnTek, Inc.
AD1K-050
In Commercial Distribution

  • 08809317540269 ()
AD1K-050

  • White blood cell count IVD, reagent
For Use with Pak12G
IMMUCOR GTI DIAGNOSTICS, INC.
404597
Not in Commercial Distribution

  • 10888234500612 ()
404597

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent
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