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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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No Description
ESTAR TECHNOLOGIES LTD
12531102GLVAS
In Commercial Distribution

  • 07290015874014 ()
12531102GLVAS

  • Haematological concentrate system preparation kit, platelet concentration
Negative control reagent for Anti-D Monoclonal Blood Grouping Reagents (210524-210525-210526) for manual tube technique
DIAGAST
210543
In Commercial Distribution

  • 23661562105438 ()
  • 13661562105431 ()
210543

  • Antisera matrix (non-reactive) IVD, control
No Description
ESTAR TECHNOLOGIES LTD
PPK3B
In Commercial Distribution

  • 07290015874502 ()


  • Haematological concentrate system preparation kit, platelet concentration
No Description
ESTAR TECHNOLOGIES LTD
52FF
In Commercial Distribution

  • 07290015874373 ()
52FF

  • Haematological concentrate system preparation kit, platelet concentration
No Description
ALMA LASERS LTD.
1
In Commercial Distribution

  • 07290110123055 ()
AAVF16042301

  • Liposuction system
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
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
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 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
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
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