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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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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
Thawing and warming device for HPC, blood products, IV solution
Barkey GmbH & Co. KG
US-C&G 2.Gen
In Commercial Distribution

  • 04059201002135 ()
00010340

  • Cryopreserved blood/tissue thawing unit
Thawing and warming device for frozen plasma (FFP, PF24 ,AHF), Whole Blood, RBC and IV solution
Barkey GmbH & Co. KG
US-C&G
In Commercial Distribution

  • 04059201001817 ()
00003475

  • Cryopreserved blood/tissue thawing unit
Thawing and warming device for frozen plasma (FFP, PF24 ,AHF), Whole Blood, RBC and IV solution
Barkey GmbH & Co. KG
US-V
In Commercial Distribution

  • 04059201001701 ()
00003296

  • Cryopreserved blood/tissue thawing unit
Thawing and warming device for frozen Plasma (FFP, PF24, AHF), Whole Blood, RBC and IV solution
Barkey GmbH & Co. KG
US-TCP
In Commercial Distribution

  • 04059201000018 ()
00000460

  • Cryopreserved blood/tissue thawing unit
Thawing and warming device for frozen Plasma (FFP, PF24, AHF), Whole Blood, RBC and IV solution
Barkey GmbH & Co. KG
US
In Commercial Distribution

  • 04059201000001 ()
00000448

  • Cryopreserved blood/tissue thawing unit
Fenwal DXT Relay is a Microsoft Windows-based software application intended to be used by trained blood center professionals to receive and transmit data between blood bank instruments (apheresis and nonapheresis) and computer systems. The data may also be stored in and accessed from Fenwal DXT Relay’s database
FENWAL, INC.
2.2
In Commercial Distribution

  • 00811137013050 ()
5S9804

  • Blood bank information system application software
  • Medical equipment clinical data interfacing software
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