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

  • 05020583810020 ()


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

  • 05020583620018 ()


  • Package sealing unit
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
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
Modified LISS-Enhancement media for TANGO instruments and tube test; 50 ml
Bio-Rad Medical Diagnostics GmbH
805200100
In Commercial Distribution

  • 07611969950898 ()
805200100

  • Low ionic-strength salt solution (LISS) immunohaematology reagent IVD
Modified LISS-Enhancement media for TANGO instruments and tube test; 50 ml
Bio-Rad Medical Diagnostics GmbH
805200100
In Commercial Distribution

  • 07611969965731 ()
805200100

  • Low ionic-strength salt solution (LISS) immunohaematology reagent IVD
NexLynk DMS version 4.x.x
HAEMONETICS CORPORATION
4.x.x
In Commercial Distribution

  • 00812747010187 ()


  • Blood bank information system application software
SafeTrace Tx version 3.x.x
HAEMONETICS CORPORATION
3.x.x
In Commercial Distribution

  • 00812747010101 ()


  • Blood bank information system application software
BloodTrack version 4.x.x
HAEMONETICS CORPORATION
4.x.x
In Commercial Distribution

  • 00812747010002 ()


  • Clinical laboratory information system application software
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
PCS2, LIST NO,06002-110-EXP-EW
HAEMONETICS CORPORATION
06002-110-EXP-EW
In Commercial Distribution

  • 30812747011970 ()


  • Autotransfusion system blood component processing set
Contra Angle 70:1
Nouvag AG
5065NOU
In Commercial Distribution

  • ENOU5065NOU0 ()


  • Line-powered dental drilling/sawing system handpiece
Contra Angle 16:1 Endodontics
Nouvag AG
5061NOU
In Commercial Distribution

  • ENOU5061NOU0 ()


  • Line-powered dental drilling/sawing system handpiece
Contra Angle 8:1 Endodontics
Nouvag AG
5057NOU
In Commercial Distribution

  • ENOU5057NOU0 ()


  • Line-powered dental drilling/sawing system handpiece
Contra Angle 32:1
Nouvag AG
5054NOU
In Commercial Distribution

  • ENOU5054NOU0 ()


  • Line-powered dental drilling/sawing system handpiece
Contra Angle 20:1 LED
Nouvag AG
5052nou
In Commercial Distribution

  • ENOU5052NOU0 ()


  • Line-powered dental drilling/sawing system handpiece
Contra Angle 1:1
Nouvag AG
5051NOU
In Commercial Distribution

  • ENOU5051NOU0 ()


  • Line-powered dental drilling/sawing system handpiece
Contra Angle 1:1
Nouvag AG
5050NOU
In Commercial Distribution

  • ENOU5050NOU0 ()


  • Line-powered dental drilling/sawing system handpiece
Clip for Contra Angle
Nouvag AG
1881
In Commercial Distribution

  • ENOU18819 ()
  • ENOU18810 ()


  • Line-powered dental drilling/sawing system handpiece
Base Mold 24 x 24 x 5 mm
SAKURA FINETEK U.S.A., INC.
4163
In Commercial Distribution

  • 00615233078100 ()
4163

  • Tissue embedding mould IVD, reusable
24 X 24 2 PLY DRAPE T180 MIST
Encompass Group, L.L.C.
CD0033
In Commercial Distribution

  • 50609953925986 ()
  • 00609953925981 ()


  • Patient surgical drape, reusable
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