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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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Haemonetics - 10887691000703

LRF High Efficiency Leukocyte Reduction Filtration System for Platelets
HAEMONETICS CORPORATION
LRFP
In Commercial Distribution

  • 30887691000707 ()
  • 10887691000703 ()


  • Blood transfusion filter

Haemonetics - 10887691000437

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

Dr.PRP - 08809410200060

The Dr. PRP is an individually packaged sterile, single-use, disposable concentrating unit composed of medical-grade polymer and elastomer. The concentrating unit has 20ml of volume capacity and is designed to work with a sing rotor type general-purpose centrifuge.
Rmedica Co.,Ltd
Dr.PRP
In Commercial Distribution

  • 08809410200060 ()
RMLFT-001(EN)

  • Apheresis system

Dr.PRP - 08809410200008

The Dr.PRP is provided as individually packaged sterile, single-use, disposable concentrating unit which is composed of medical grade polymer and elastomer. The concentrating unit has 20 ml of volume capacity and is designed to work with a swing rotor type general-purpose centrifuge.
Rmedica Co.,Ltd
Dr.PRP
In Commercial Distribution

  • 08809410200008 ()
RMLFT-001(EN)

  • Apheresis system

Barkey plasmatherm C&G - 04059201001817

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

plasmatherm - 04059201000018

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

Barkey plasmatherm C&G - 04059201002135

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

Barkey plasmatherm V - 04059201001701

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

plasmatherm - 04059201000001

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

BioHorizons - 00847236016043

IntraSpin System 220V, Procedure Pack
BIOHORIZONS IMPLANT SYSTEMS, INC
LPRF220
In Commercial Distribution

  • 00847236016043 ()


  • Haematological concentrate system

BioHorizons - 00847236015978

Xpression Box
BIOHORIZONS IMPLANT SYSTEMS, INC
CTRZ
In Commercial Distribution

  • 00847236015978 ()
  • 00847236019822 ()


  • Haematological concentrate system

BioHorizons - 00847236015886

IntraSpin Rotor, 110v & 220v
BIOHORIZONS IMPLANT SYSTEMS, INC
BROTORZ
In Commercial Distribution

  • 00847236015886 ()


  • Centrifuge rotor, ultracentrifuge

BioHorizons - 00847236015862

IntraSpin Power Cord, 110v
BIOHORIZONS IMPLANT SYSTEMS, INC
BPOWER110Z
In Commercial Distribution

  • 00847236015862 ()


  • Electrical mains power cable

BioHorizons - 00847236015848

IntraSpin Fuse 220v
BIOHORIZONS IMPLANT SYSTEMS, INC
BFUSE220Z
In Commercial Distribution

  • 00847236015848 ()


  • Haematological concentrate system

BioHorizons - 00847236015831

IntraSpin Fuse 110v
BIOHORIZONS IMPLANT SYSTEMS, INC
BFUSE110Z
In Commercial Distribution

  • 00847236015831 ()


  • Haematological concentrate system

BioHorizons - 00847236015824

IntraSpin Centrifuge, 220 volts
BIOHORIZONS IMPLANT SYSTEMS, INC
IS220Z
In Commercial Distribution

  • 00847236015824 ()


  • Haematological concentrate system

Puriblood - 04719878520515

No Description
PURIBLOOD MEDICAL CO., LTD.
LRW-50-08-PS
In Commercial Distribution

  • 14719878520512 ()
  • 04719878520515 ()


  • Blood transfusion set, non-exchange

Puriblood - 04719878520508

No Description
PURIBLOOD MEDICAL CO., LTD.
LRW-50-07-PS
In Commercial Distribution

  • 14719878520505 ()
  • 04719878520508 ()


  • Blood transfusion set, non-exchange

Puriblood - 04719878520492

No Description
PURIBLOOD MEDICAL CO., LTD.
LRW-50-06-PS
In Commercial Distribution

  • 14719878520499 ()
  • 04719878520492 ()


  • Blood transfusion set, non-exchange

Puriblood - 04719878520485

No Description
PURIBLOOD MEDICAL CO., LTD.
LRW-50-05-PS
In Commercial Distribution

  • 14719878520482 ()
  • 04719878520485 ()


  • Blood transfusion set, non-exchange

Puriblood - 04719878520478

No Description
PURIBLOOD MEDICAL CO., LTD.
LRW-50-04-PS
In Commercial Distribution

  • 14719878520475 ()
  • 04719878520478 ()


  • Blood transfusion set, non-exchange

Puriblood - 04719878520461

No Description
PURIBLOOD MEDICAL CO., LTD.
LRW-50-01-PS
In Commercial Distribution

  • 14719878520468 ()
  • 04719878520461 ()


  • Blood transfusion set, non-exchange

Puriblood - 04719878520003

No Description
PURIBLOOD MEDICAL CO., LTD.
LRW-50-12-PS
In Commercial Distribution

  • 04719878520003 ()
  • 14719878520000 ()


  • Blood transfusion set, non-exchange

Virtue CPKit - 04719875912177

No Description
AEON BIOTHERAPEUTICS CORP.
ABA-15Q
In Commercial Distribution

  • 04719875912177 ()


  • Haematological concentrate system preparation kit, platelet concentration

Virtue CPKit - 04719875912160

No Description
AEON BIOTHERAPEUTICS CORP.
ABA-15S
In Commercial Distribution

  • 04719875912160 ()


  • Haematological concentrate system preparation kit, platelet concentration

Virtue CPKit - 04719875912153

No Description
AEON BIOTHERAPEUTICS CORP.
APA-10G
In Commercial Distribution

  • 04719875912153 ()


  • Haematological concentrate system preparation kit, platelet concentration

Virtue CPKit - 04719875912146

No Description
AEON BIOTHERAPEUTICS CORP.
APA-15G
In Commercial Distribution

  • 04719875912146 ()


  • Haematological concentrate system preparation kit, platelet concentration

Virtue CPKit - 04719875912139

No Description
AEON BIOTHERAPEUTICS CORP.
APA-15D
In Commercial Distribution

  • 04719875912139 ()


  • Haematological concentrate system preparation kit, platelet concentration

Virtue CPKit - 04719875912122

No Description
AEON BIOTHERAPEUTICS CORP.
APA-15
In Commercial Distribution

  • 04719875912122 ()


  • Haematological concentrate system preparation kit, platelet concentration

Aeon CPKit - 04719875912054

No Description
AEON BIOTHERAPEUTICS CORP.
APA-15D
In Commercial Distribution

  • 04719875912054 ()


  • Haematological concentrate system preparation kit, platelet concentration

Aeon CPKit - 04719875912047

No Description
AEON BIOTHERAPEUTICS CORP.
ABA-15Q
In Commercial Distribution

  • 04719875912047 ()


  • Haematological concentrate system preparation kit, platelet concentration

Aeon CPKit - 04719875912030

No Description
AEON BIOTHERAPEUTICS CORP.
ABA-15S
In Commercial Distribution

  • 04719875912030 ()


  • Haematological concentrate system preparation kit, platelet concentration

Aeon CPKit - 04719875912023

No Description
AEON BIOTHERAPEUTICS CORP.
APA-10G
In Commercial Distribution

  • 04719875912023 ()


  • Haematological concentrate system preparation kit, platelet concentration

Aeon CPKit - 04719875912016

No Description
AEON BIOTHERAPEUTICS CORP.
APA-15G
In Commercial Distribution

  • 04719875912016 ()


  • Haematological concentrate system preparation kit, platelet concentration

Aeon CPKit - 04719875912009

No Description
AEON BIOTHERAPEUTICS CORP.
APA-15
In Commercial Distribution

  • 04719875912009 ()


  • Haematological concentrate system preparation kit, platelet concentration

Trima Accel® - 05020583810013

Automated Blood Collection System
TERUMO BCT, INC.
81001
In Commercial Distribution

  • 05020583810013 ()


  • Apheresis system

COBE® Spectra - 05020583719002

Refurbished COBE® Spectra Apheresis System
TERUMO BCT, INC.
71900
Not in Commercial Distribution

  • 05020583719002 ()


  • Blood transfer set

COBE® Spectra - 05020583711006

Single Needle Set
TERUMO BCT, INC.
71100
Not in Commercial Distribution

  • 05020583711006 ()


  • Blood transfer set

COBE® Spectra - 05020583706309

Bone Marrow Processing Set
TERUMO BCT, INC.
70630
In Commercial Distribution

  • 05020583706309 ()
  • 35020583706300 ()


  • Blood transfer set

COBE® Spectra - 05020583706293

White Blood Cell-Functionally Closed Tubing
TERUMO BCT, INC.
70629
Not in Commercial Distribution

  • 05020583706293 ()
  • 35020583706294 ()


  • Blood transfer set
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