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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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BBIMS is Blood Establishment Computer Software. It is designed for use in a blood center to support the entry and eligibility processing for blood donors. It is used for manufacturing blood products and for shipping those products to customer hospitals for eventual transfusion.
CARTER BLOODCARE
2.06
In Commercial Distribution

  • 00857222008006 ()


  • 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
MEDHOST OF TENNESSEE, INC.
9.0
In Commercial Distribution

  • 00869202000214 ()


  • Blood bank information system application software
The bexWISE API (v1.0) is for use in blood establishments to facilitate communication between 510(k) cleared Blood Establishment Computer Systems (BECS), allowing the exchange of donor and donation-related data used to determine donor eligibility and donation suitability.
IT SYNERGISTICS, LLC
1.0
In Commercial Distribution

  • 00867268000421 ()


  • Blood bank information system application software
The LifeTec Elite system is a blood establishment computer system that receives and stores data in the manufacture of blood and blood components, which blood establishments rely on for making decisions regarding the release of blood components for transfusion or further manufacturing. Specifically, laboratory testing, product manufacturing and inventory control/distribution.
IT SYNERGISTICS, LLC
1.0
In Commercial Distribution

  • 00867268000414 ()


  • Blood bank information system application software
The DoVac Elite system is a web-based application that provides functions for managing donors, donations and the collection process. The system identifies results and responses throughout the process that can be considered ‘high-risk’ to the general blood supply which notifies and allows a staff member to complete a review to determine donor suitability. The DoVac Elite application is capable of capturing all information in the collection process: registration, physical exam, computer assisted medical questionnaire, donor consent, donation identification number assignment, phlebotomy, supervisor review and audit. The system maintains a complete record of all interactions throughout including the donation process, device interfaces, auditing and donor/donation maintenance functions.
IT SYNERGISTICS, LLC
2.0
In Commercial Distribution

  • 00867268000407 ()


  • Blood bank information system application software
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
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
SCC SOFT COMPUTER
1.0.0.17
In Commercial Distribution

  • 00859474006946 ()


  • Bedside information system application software
No Description
SCC SOFT COMPUTER
4.5.4.1
In Commercial Distribution

  • 00859474006656 ()


  • Blood bank information system application software
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