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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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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

Fenwal DXT Relay - 00811137013050

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

ALYX 2RBC LR Kit with Saline Spike - 00811137012992

For Collection of Two Leukoreduced Red Blood Cell Products by Centrifugation. For Use with the ALYX System. Sterile Fluid Path.
FENWAL, INC.
4R5742
In Commercial Distribution

  • 00811137012992 ()
  • 10811137012999 ()
4R5742

  • Apheresis system tubing set

ALYX Plasma Kit - 00811137012916

For Collection of Plasma Product by Centrifugation. For Use With the ALYX System. Sterile Fluid Path.
FENWAL, INC.
4R5730
Not in Commercial Distribution

  • 00811137012916 ()
  • 10811137012913 ()
4R5730

  • Apheresis system tubing set

Leukoconnect - 00811137010486

LEUKOCONNECT Pre-Storage Sterile Connect Leukoreduction Set with SEPACELL RS-2000 Filter for Red Blood Cells in Additive Solution. Sterile Fluid Path
FENWAL, INC.
4C4300
Not in Commercial Distribution

  • 10811137010483 ()
  • 00811137010486 ()
  • 0FE04C4300 ()
4C4300

  • Blood transfusion set, non-exchange

NA - 00811137010462

SEPACELL Pre-Storage Leukocyte Reduction Set for Red Cells. Sterile Fluid Path
FENWAL, INC.
4C2300
Not in Commercial Distribution

  • 10811137010469 ()
  • 00811137010462 ()
  • 0FE04C2300 ()
4C2300

  • Blood transfusion set, non-exchange

NA - 00811137010431

Sepacell PLD-10ALeukocyte Reduction Y-Administration Set. Sterile Fluid Path
FENWAL, INC.
4C4502
In Commercial Distribution

  • 10811137010438 ()
  • 00811137010431 ()
4C4502

  • Blood transfusion set, non-exchange

ALYX™ RBC/Plasma Kit - 00811137010134

For Collection of One Leukoreduced Red Blood Cell Product and Concurrent Plasma Product by Centrifugation. For Use With the ALYX™ System. Sterile Fluid Path.
FENWAL, INC.
4R5700
In Commercial Distribution

  • 00811137010134 ()
  • 10811137010131 ()
4R5700

  • Apheresis system tubing set

Determine™ HIV–1/2 Ag/Ab Combo Controls - 00811877011125

The Determine™ HIV-1/2 Ag/Ab Combo Controls are quality control reagents for use with the Determine™ HIV-1/2 Ag/Ab Combo Assay only.
Alere Scarborough, Inc.
7D2628
In Commercial Distribution

  • 00811877011125 ()


  • HIV1/HIV2 antigen/antibody IVD, control

Determine™ HIV–1/2 Ag/Ab Combo - 00811877011101

Determine™ HIV–1/2 Ag/Ab Combo is an in vitro, visually read, qualitative immunoassay for the simultaneous detection of HIV-1 p24 antigen (Ag) and antibodies (Ab) to HIV-1 and HIV-2 in human serum, plasma, capillary (fingerstick) whole blood or venipuncture (venous) whole blood.
Alere Scarborough, Inc.
7D2648
In Commercial Distribution

  • 00811877011101 ()


  • HIV1/HIV2 antigen/antibody IVD, kit, rapid ICT, clinical
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