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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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e-Delphyn Donor version 11.x.x (US)
Gpi Usa, Inc.
11(US)
In Commercial Distribution

  • 00860007282706 ()


  • Blood bank information system
Regulated Software Application (RSA), Version 2.0 is a stand-alone blood establishment computer software application (BECS) that provides management controls and information services that have been designed to assist personnel in the operation of a blood center.
ARC-ONE SOLUTIONS, LLC
2.0.0.0
In Commercial Distribution

  • 00860006793708 ()
2.0.0.0

  • Blood bank information system application software
ADIMS is a stand-alone blood establishment computer software application (BECS) that provides for the management of plasma and whole blood donors for an RBC immunization program as well as the record and inventory management of immunogen red blood cells. The application is used to determine donor eligibility and release of the blood or blood component for transfusion as well as tracking the preparation of immunogen components (vials) for storage and distribution. Additionally, ADIMS allows for the tracking the recipient of transfused immunogen RBCs
Csl Plasma Inc.
1.0
In Commercial Distribution

  • 00860007397615 ()


  • Blood bank information system application software
LOGIC 4.0 is a web-based software application used to support daily operations of product logistics, primarily organizing and controlling the movement of plasma units between facilities such as warehouses and fractionators. The application also communicates observations or post donation information, status and recalls between collection, warehouse and fractionation facilities. LOGIC provides interface capabilities with sub-systems.
Csl Plasma Inc.
4.0
In Commercial Distribution

  • 00860007397608 ()


  • Blood bank information system application software
Surround 5.x
Gpi Usa, Inc.
5.x
In Commercial Distribution



  • Blood bank information system
ElDorado Donor 3.x.x
Gpi Usa, Inc.
3.x.x
In Commercial Distribution



  • Blood bank information system
cmTriage is a passive notification for prioritization-only, parallel-workflow software tool used by radiologists to prioritize specific patients within the standard-of-care image worklist for 2D FFDM screening mammograms. cmTriage uses an artificial intelligence algorithm to analyze 2D FFDM screening mammograms and flags those that are suggestive of the presence of at least one suspicious finding at the exam level. These flags are viewed by the radiologist via their Picture Archiving and Communication System (PACS) worklist. The decision to use cmTriage codes and how to use cmTriage codes is ultimately up to the radiologist. cmTriage does not send a proactive alert directly to the radiologist. Radiologists are responsible for reviewing each exam on a diagnostic viewer according to the current standard of care. cmTriage is limited to the categorization of exams, does not provide any diagnostic information beyond triage and prioritization, does not remove images from the radiologist’s worklist, and should not be used in lieu of full patient evaluation, or relied upon to make or confirm diagnosis. cmTriage is for prescription use only.
Curemetrix, Inc.
V1.0
In Commercial Distribution

  • 00860006442668 ()


  • Radiology DICOM image processing application software
No Description
MEDHOST OF TENNESSEE, INC.
9.0
In Commercial Distribution

  • 00869202000214 ()


  • Blood bank information system application software
CorVista System with PH Add-On
Analytics for Life Inc.
CorVista System with PH Add-On
In Commercial Distribution

  • 00869059000443 ()


  • Multiparameter physiologic analysis workstation
No Description
Edan Instruments, Inc.
ECG-Viewer
In Commercial Distribution

  • 06944413808157 ()


  • Electrocardiograph, professional, multichannel
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