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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® NexSys PCS® System - 30812747019808

Persona™ Plasma Pooling Bottles
HAEMONETICS CORPORATION
0699S-12
In Commercial Distribution

  • 00812747019807 ()
  • 30812747019808 ()


  • Apheresis system tubing set

SCD Welding Wafer - 35020583260314

3-NCC987 SCD Wafer
TERUMO BCT, INC.
3NCC987
In Commercial Distribution

  • 55020583260318 ()
  • 35020583260314 ()
  • 05020583260313 ()


  • Package sealing unit

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

Ranger™ - 50707387781922

3M™ Ranger™ Hose Cap, 12 per Case, 90026
3M COMPANY
90026
In Commercial Distribution

  • 50707387781922 ()
  • 00707387781927 ()
90026

  • Conduction blood/fluid warmer set

HemoCue® Plasma/Low Hb Photometer - 07311091203144

HemoCue Plasma/Low Hb Photometer mg/dL
Hemocue AB
120314
In Commercial Distribution

  • 07311091203144 ()
120314

  • Haemoglobin analyser IVD, point-of-care

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
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