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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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Bair Hugger™ - 50608223241108

3M™ Ranger® Fluid Warming Set, Standard Flow, 10 Per Case 24110
3M COMPANY
24110
In Commercial Distribution

  • 50608223241108 ()
  • 00608223241103 ()
24110

  • Conduction blood/fluid warmer 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

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

Selphyl PRFM Tube - 00851802007120

Blood separation tube for PRFM
Factor Medical, Inc.
0364
In Commercial Distribution

  • 00851802007120 ()

  • Total Volume: 10 Milliliter
0364

  • Haematological concentrate system preparation kit, platelet concentration

Haemonetics® NexSys PCS® System - 30812747019228

Persona™ Plasma Pooling Bottles
HAEMONETICS CORPORATION
0697S-00
In Commercial Distribution

  • 30812747019228 ()

  • Total Volume: 1200 Milliliter


  • Apheresis system tubing set

Segment Sampler (SEG) - 19555240401332

SEG is intended to aid extraction of a biological fluid sample from a segmented piece of tubing.
ITL ASIA PACIFIC SDN. BHD.
A200200
Not in Commercial Distribution

  • 19555240401349 ()
  • 19555240401332 ()
  • 19555240401356 ()
A200200

  • Blood donor bag segment sampling IVD
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