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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™ 2RBC-LR Kit - 00811137010127

For Collection of Two Leukoreduced Red Blood Cell Products by Centrifugation. For Use With the ALYX™ System. Sterile Fluid Path.
FENWAL, INC.
4R5720
In Commercial Distribution

  • 10811137010124 ()
  • 00811137010127 ()
4R5720

  • Apheresis system tubing set

MLB 2 - 07611969965731

Modified LISS-Enhancement media for TANGO instruments and tube test; 50 ml
Bio-Rad Medical Diagnostics GmbH
805200100
In Commercial Distribution

  • 07611969965731 ()
805200100

  • Low ionic-strength salt solution (LISS) immunohaematology reagent IVD

MLB 2 - 07611969950898

Modified LISS-Enhancement media for TANGO instruments and tube test; 50 ml
Bio-Rad Medical Diagnostics GmbH
805200100
In Commercial Distribution

  • 07611969950898 ()
805200100

  • Low ionic-strength salt solution (LISS) immunohaematology reagent IVD

NexLynk DMS - 00812747010187

NexLynk DMS version 4.x.x
HAEMONETICS CORPORATION
4.x.x
In Commercial Distribution

  • 00812747010187 ()


  • Blood bank information system application software

SafeTrace Tx - 00812747010101

SafeTrace Tx version 3.x.x
HAEMONETICS CORPORATION
3.x.x
In Commercial Distribution

  • 00812747010101 ()


  • Blood bank information system application software

BloodTrack - 00812747010002

BloodTrack version 4.x.x
HAEMONETICS CORPORATION
4.x.x
In Commercial Distribution

  • 00812747010002 ()


  • Clinical laboratory information system application software

Celling ART PRP 2-Step Mini Kit - 00817771028870

ART PRP 2-Step Processing Kit - Mini - w/o blood draw
Celling Biosciences
1651-0002
In Commercial Distribution

  • 00817771028870 ()
1651-0002

  • Haematological concentrate system preparation kit, platelet concentration

Celling ART PRP 2-Step 120 Kit - 00817771028856

ART PRP 2-Step Processing Kit - 120
Celling Biosciences
1651-0005
In Commercial Distribution

  • 00817771028856 ()
1651-0005

  • Haematological concentrate system preparation kit, platelet concentration

Celling ART PRP 2-Step 60 Kit - 00817771028825

ART PRP 2-Step Processing Kit - 60
Celling Biosciences
1651-0004
In Commercial Distribution

  • 00817771028825 ()
1651-0004

  • Haematological concentrate system preparation kit, platelet concentration

HAEMONETICS PCS 2 APHERESIS SYSTEM - 30812747011970

PCS2, LIST NO,06002-110-EXP-EW
HAEMONETICS CORPORATION
06002-110-EXP-EW
In Commercial Distribution

  • 30812747011970 ()


  • Autotransfusion system blood component processing set
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