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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 Platelets with Optional Plasma and/or Red Blood Cells. For Platelet Storage in Plasma or Platelet Additive Solution Plus Plasma. For Use with the AMICUS Separator. Sterile Fluid Path.
Fresenius Kabi AG
4R2353
In Commercial Distribution

  • 14086000101377 ()
  • 04086000101370 ()
4R2353

  • Apheresis system tubing set
500 ML. Cryopreservative processing solution for manufacture of Red Blood Cells, Frozen. Not for intravenous infusion.
Fresenius Kabi AG
4A7833
In Commercial Distribution

  • 04086000101288 ()
  • 14086000101285 ()
4A7833

  • Blood storage solution, freezing
400 ML. Cryopreservative processing solution for manufacture of Red Blood Cells, Frozen. Not for intravenous infusion.
Fresenius Kabi AG
4A7831
In Commercial Distribution

  • 04086000101271 ()
  • 14086000101278 ()
4A7831

  • Blood storage solution, freezing
For Collection of Plasma by Membrane Filtration. For Use With the Aurora Xi Instrument. Sterile Fluid Path.
Fresenius Kabi AG
6R2600
In Commercial Distribution

  • 04086000101097 ()
  • 14086000101094 ()
6R2600

  • Apheresis system tubing set
A software upgrade package (accessory) to the Aurora Plasmapheresis System (primary device). For collection of plasma by membrane filtration.
Fresenius Kabi AG
6R2013
In Commercial Distribution

  • 04086000101059 ()
  • 14086000101056 ()
6R2013

  • 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
4R5742
In Commercial Distribution

  • 14086000101032 ()
  • 04086000101035 ()
  • 00811137012992 ()
4R5742

  • Apheresis system tubing set
For Collection of Plasma Product by Centrifugation. For Use With the ALYX System. Sterile Fluid Path.
Fresenius Kabi AG
4R5730
In Commercial Distribution

  • 04086000101028 ()
  • 14086000101025 ()
4R5730

  • Apheresis system tubing set
For Collection of One Leukoreduced Red Blood Cell Product and Concurrent Plasma Product by Centrifugation. For Use with the ALYX System. Sterile Fluid Path.
Fresenius Kabi AG
X4R5700
In Commercial Distribution

  • 04086000101004 ()
  • 14086000101001 ()
X4R5700

  • Apheresis system tubing set
AMICUS Apheresis Kit – Double Needle with Platelet Additive Solution Connector
Fresenius Kabi AG
X6R2302
In Commercial Distribution

  • 14086000100967 ()
  • 04086000100960 ()
X6R2302

  • Apheresis system tubing set
No Description
MILLIPORE (U.K.) LIMITED
6708858
In Commercial Distribution

  • 04065266566086 ()
6708858

  • Non-blood cell primer/calibrator/control material IVD, reagent
LRF6 High Efficiency Leukocyte Reduction Filter for Platelets with Attached 600 mL Transfer Bag
HAEMONETICS CORPORATION
LRF6BLA
In Commercial Distribution

  • 30887691305796 ()
  • 10887691305792 ()


  • Blood transfusion filter
Leukotrap High Efficiency Leukocyte Reduction Filtration System for Red Blood Cells with BPF4 Filter
HAEMONETICS CORPORATION
BPFBLA
In Commercial Distribution

  • 30887691304218 ()
  • 10887691304214 ()


  • Blood transfusion filter
High Efficiency Post-Process Filter System for Leukocyte Removal From Red Cells
HAEMONETICS CORPORATION
BPFAPLUS
In Commercial Distribution

  • 10887691313940 ()
  • 30887691313944 ()


  • Blood transfusion filter
Platelet Pool and Store Set with In-Line Leukocyte Reduction Filter and eBDS
HAEMONETICS CORPORATION
732-82
In Commercial Distribution

  • 30887691310684 ()
  • 10887691310680 ()


  • Blood/tissue storage/culture container
Platelet Pool and Store Set with eBDS
HAEMONETICS CORPORATION
732-80
In Commercial Distribution

  • 30887691307882 ()
  • 10887691307888 ()


  • Blood/tissue storage/culture container
LRF10 High Efficiency Leukocyte Reduction Filter for Platelets with Attached 1.3 L CLX Transfer Bag
HAEMONETICS CORPORATION
LRF10BLA
In Commercial Distribution

  • 30887691305307 ()
  • 10887691305303 ()


  • Blood transfusion filter
Neonatal High Efficiency Leukocyte Reduction Filter for Red Blood cells with Attached 175 mL PVC Aliquot Bag with Needleless Injection Port
HAEMONETICS CORPORATION
NEO1
In Commercial Distribution

  • 30887691003876 ()
  • 10887691003872 ()


  • Blood transfusion filter
BPF Leukocyte Reduction Filteration System
HAEMONETICS CORPORATION
BPFB
In Commercial Distribution

  • 30887691000752 ()
  • 10887691000758 ()


  • Blood transfusion filter
LRF High Efficiency Leukocyte Reduction Filtration System for Platelets
HAEMONETICS CORPORATION
LRFP
In Commercial Distribution

  • 30887691000707 ()
  • 10887691000703 ()


  • Blood transfusion filter
LRF 10 High Efficiency Leukocyte Reduction Filter for platelets with Attached 1.3L CLX Transfer Bag
HAEMONETICS CORPORATION
LRF10S
In Commercial Distribution

  • 30887691000431 ()
  • 10887691000437 ()


  • Blood transfusion filter
LIFECODES LifeScreen XP is a manual, qualitative bead-based immunoassay used to detect IgG antibodies to HLA Class I and Class II molecules in patients sensitized to HLA by transfusion, pregnancy, or transplantation to aid donor and recipient match in transfusion or transplantation.
IMMUCOR GTI DIAGNOSTICS, INC.
628220
In Commercial Distribution

  • 10888234500841 ()
628220

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
For Use with HLA-SSO Typing Kits
IMMUCOR GTI DIAGNOSTICS, INC.
628515UDI
In Commercial Distribution

  • 10888234500827 ()
628515UDI

  • Buffered sample diluent IVD
No Description
IMMUCOR GTI DIAGNOSTICS, INC.
888627
In Commercial Distribution

  • 10888234500810 ()
888627

  • Laboratory instrument/analyser application software IVD
No Description
IMMUCOR GTI DIAGNOSTICS, INC.
888623
In Commercial Distribution

  • 10888234500803 ()
888623

  • Laboratory instrument/analyser application software IVD
Five Chamber Transfer/Freezing Bag Set intended to be used for cord blood processing and freezing
Global Life Sciences Solutions USA LLC
791-12
In Commercial Distribution

  • 30636207314681 ()
  • 00636207314680 ()

  • Five chamber transfer/freezing bag
791-12

  • Umbilical cord blood collection set
25 mL Freezing Bag with Separable Chamber for blood component freezing.
Global Life Sciences Solutions USA LLC
791-05
In Commercial Distribution

  • 30636207302466 ()
  • 00636207302465 ()
  • 20636207302469 ()

  • Total Volume: 25 Milliliter
  • recommended fill volume
791-05

  • Umbilical cord blood collection set
Two transfer bags (150 mL and 200 mL) and one 25 mL freezing bag for blood component processing and freezing.
Global Life Sciences Solutions USA LLC
791-02
In Commercial Distribution

  • 30636207302442 ()
  • 00636207302441 ()

  • Total Volume: 25 Milliliter
  • recommended fill volume
791-02

  • Umbilical cord blood collection set
Two empty transfer bags with two spikes and luer adapter and associated tubing for washing blood and cellular components.
Global Life Sciences Solutions USA LLC
791-03
In Commercial Distribution

  • 30636207302435 ()
  • 00636207302434 ()

  • Total Volume: 250 Milliliter
  • maximum 250 mL fill volume per bag
791-03

  • Umbilical cord blood collection set
Weld Integrity Test Kit for TSCD®II Sterile Tubing Welder
TERUMO BCT, INC.
62003
In Commercial Distribution

  • 05020583620032 ()


  • Package sealing unit
SCD®-IIB Sterile Tubing Welder
TERUMO BCT, INC.
62002
In Commercial Distribution

  • 05020583620025 ()


  • Package sealing unit
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