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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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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

Lymphoscreen ABC-60 - 07611969952939

Human lymphocytes for 6 detections of human HLA-ABC antibodies in the complement-dependent microlymphocytotoxicity test
Bio-Rad Medical Diagnostics GmbH
823300
Not in Commercial Distribution

  • 07611969952939 ()
823300

  • HLA class I antibody identification panel IVD, kit, complement-dependent cytotoxicity (CDC)

Bromelin for Erytype - 07611969965755

Red Blood Cell Diluent for TANGO instruments, 10x10 mL
Bio-Rad Medical Diagnostics GmbH
806210100
In Commercial Distribution

  • 07611969965755 ()
806210100

  • Bromelin immunohaematology reagent IVD

IH-Card Neutral - 07611969964871

Gel card for use with the IH system; Card for antibody detection of human red blood cells; 288 cards of 6 microtubes
Bio-Rad Medical Diagnostics GmbH
813612100
In Commercial Distribution

  • 07611969964871 ()
813612100

  • ABO/Rh multiple blood grouping IVD, kit, agglutination

IH-Card Neutral - 07611969964864

Gel card for use with the IH system; Card for antibody detection of human red blood cells; 12 cards of 6 microtubes
Bio-Rad Medical Diagnostics GmbH
813610100
In Commercial Distribution

  • 07611969964864 ()
813610100

  • ABO/Rh multiple blood grouping IVD, kit, agglutination

TANGO optimo - 07611969961696

Instrument
Bio-Rad Medical Diagnostics GmbH
848900010
In Commercial Distribution

  • 07611969961696 ()
848900010

  • Immunohaematology/blood bank analyser IVD

Rejuvesol™ - 00887868260285

No Description
Citra Labs, LLC
PN-7212
In Commercial Distribution

  • 00887868260285 ()
  • 70887868260284 ()
PN-7212

  • Blood transfer set

BMS - 06976052440092

Sterile Tube Welder
Wuhan BMS Medicaltech Co., Ltd
STW6810-RFID
In Commercial Distribution

  • 06976052440092 ()


  • Laboratory tubing welder

BMS - 06976052440061

Metal Wire Cassette is a disposable part of Sterile Tube Welder
Wuhan BMS Medicaltech Co., Ltd
Metal Wire Cassette
In Commercial Distribution

  • 16976052440068 ()
  • 06976052440061 ()


  • Laboratory tubing welder
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