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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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ALYX RBC/PLASMA KIT - 04086000101004

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 - 04086000100960

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

  • 14086000100967 ()
  • 04086000100960 ()
X6R2302

  • Apheresis system tubing set

AMICUS Apheresis Kit – Single Needle with Platelet Additive Solution Connector - 04086000100953

AMICUS Apheresis Kit – Single Needle with Platelet Additive Solution Connector
Fresenius Kabi AG
X6R2301
In Commercial Distribution

  • 14086000100950 ()
  • 04086000100953 ()
X6R2301

  • Apheresis system tubing set

Plastic Storage Container - 04086000100175

Sterile Fluid Path.
Fresenius Kabi AG
X6R2350
In Commercial Distribution

  • 04086000100175 ()
  • 24086000100179 ()
  • 14086000100172 ()
X6R2350

  • Blood transfer set

Amicus MNC Apheresis Kit - Double Needle - 04086000100144

For Mononuclear Cell (MNC) Collection. For use with the AMICUS separator. Sterile Fluid Path.
Fresenius Kabi AG
X6R2326
In Commercial Distribution

  • 04086000100144 ()
  • 14086000100141 ()
X6R2326

  • Apheresis system tubing set

ORTHO Daily QC Simulated Whole Blood Quality Control Kit - 04065266566086

No Description
MILLIPORE (U.K.) LIMITED
6708858
In Commercial Distribution

  • 04065266566086 ()
6708858

  • Non-blood cell primer/calibrator/control material IVD, reagent

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

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 - 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
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