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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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Autologous Platelet System Membrane
Musculoskeletal Transplant Foundation, Inc.
910044
Not in Commercial Distribution

  • 00859070006012 ()
910044

  • Haematological concentrate system preparation kit, platelet concentration
Autologous Platelet System - RPR
Musculoskeletal Transplant Foundation, Inc.
910046
Not in Commercial Distribution

  • 00859070006005 ()
910046

  • Haematological concentrate system preparation kit, platelet concentration
For Sampling of Collected Blood and Blood Components. For Laboratory Testing Only. Sterile Fluid Path.
Fresenius Kabi AG
4R2335H
In Commercial Distribution

  • 14086000101421 ()
  • 04086000101424 ()
  • 24086000101428 ()
4R2335H

  • Blood transfer set
For the quantitative determination of hemoglobin in whole blood.
EKF-diagnostic GmbH
7049-3013-0369
In Commercial Distribution

  • 24048534001964 ()
  • 14048534001967 ()
  • 04048534001953 ()
900-500

  • Haemoglobin analyser IVD, point-of-care
24 tests without support material
Biolytical Laboratories Inc
Without Support
Not in Commercial Distribution

  • 06865979010207 ()
90-1020

  • HIV1/HIV2 antigen IVD, kit, rapid ICT, clinical
Single-use rapid assay for the detection of antibodies to Human Immunodeficiency Virus Type 1 and Type 2 (HIV-1, HIV-2)
Biolytical Laboratories Inc
Single
Not in Commercial Distribution

  • 06865979010191 ()
90-1019

  • HIV1/HIV2 antigen IVD, kit, rapid ICT, clinical
24 Tests with support materials
Biolytical Laboratories Inc
With Support
Not in Commercial Distribution

  • 06865979010184 ()
90-1018

  • HIV1/HIV2 antigen IVD, kit, rapid ICT, clinical
PK7400 Automated Microplate System
Beckman Coulter, Inc.
B53299
In Commercial Distribution

  • 14987666543344 ()


  • Blood group/antibody screening analyser IVD
PK7300
Beckman Coulter, Inc.
N3209000
In Commercial Distribution

  • 14987666535721 ()
N3209000

  • Blood group/antibody screening analyser IVD
The PatientTouch Blood Product Administration is a software application that helps support nurse documentation of blood product administrations. Additionally, through the use of bar code technology, the solution will electronically acknowledge a match between the blood unit to be administered and the patient. The software It is limited to use in acute care hospitals by licensed, trained, and registered nursing professionals.
PATIENTSAFE SOLUTIONS, INC.
3.3.1
In Commercial Distribution

  • 00853209005006 ()
PTA BPA

  • Blood bank information system application software
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