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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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BRAINOMIX LIMITED
11.1
In Commercial Distribution

  • B720BX360TRIAGEICH1110 ()


  • X-ray image interpretive software
SGP (acronym for Sistema de Gestion del Plasma or Plasma Management System) is an application designed to manage the logistics of plasma stored in a central warehouse of a plasma manufacturing organization or a fractionation facility. This includes all activities from receipt of plasma to fractionation, as it relates to storage and control of the plasma units.
BIOMAT USA, INC.
7
In Commercial Distribution

  • 00817955020010 ()


  • Blood bank information system application software
GDS (acronym for Grifols Donation System) is an application designed to manage plasma donor center activities such as donor eligibility, unit suitability, shipments (units and samples), and sample management. GDS software provides management controls and information services modules that have been designed to assist personnel in the operational core functions in the company’s plasma donor centers.
BIOMAT USA, INC.
1
In Commercial Distribution

  • 00817955020003 ()


  • Blood bank information system application software
CTB software versions 2.3+ Annalise Critical Care AI is a medical device software application which uses artificial intelligence (AI) algorithms to prioritize suggested findings within a clinical triage workflow of radiological imaging studies.
ANNALISE-AI PTY LTD
2.3+
In Commercial Distribution

  • G140ANNALISECONTAINER70 ()
Annalisecontainer7

  • Radiology DICOM image processing application software
StrokeViewer LVO Triaging is a notification only cloud-based image processing software application using artificial intelligence algorithms to analyze patient imaging data in parallel to the standard of care imaging interpretation.
NICo-Lab B.V.
3
In Commercial Distribution

  • 08720299502338 ()


  • X-ray image interpretive software
IH-AbID Integrated Antibody Identification Software is an optional software module for IHCom that provides the user with guidance and information on the identification of antibodies to red blood cell antigens subsequent to the immunohematology testing with the IH-system. The IH-AbID module graphically displays the ruling out of antibodies to red blood cell antigens by reproducing the same logic techniques of antibody identification used in blood transfusion laboratories. For use by trained laboratory personnel, in a (blood transfusion) laboratory environment.
Bio-Rad Medical Diagnostics GmbH
12010902
In Commercial Distribution

  • 03610522136421 ()
12010902

  • Laboratory instrument/analyser application software IVD
GeTraP is a software application used to support daily operations of product logistics primarily organizing and controlling the information about the transport of plasma units between facilities such as warehouses and fractionators. GeTraP supports trained personnel in tracking data received from suppliers, verifying each plasma units’ suitability for further manufacture.
KEDRION SPA
3.x.x.x
In Commercial Distribution

  • 08055271669762 ()


  • Blood bank information system application software
Blood Typing Manager is a transfusion data manager software that aids in interfacing and managing data between immunohematology instruments, Blood Establishment Computer Software and Laboratory Information System. Blood Typing Manager includes the following features: • Bidirectional connectivity with one or more LIS. • Provides the ability to centralize the management of Quality Control. • Allows user to view and validate results remotely prior to export to LIS. • Allows to create and print reports. Blood Typing Manager is a stand-alone software specifically designed to aid in interfacing and managing data among immunohematology instruments, Blood Establishment Computer Software and Laboratory Information System as part of the DG Gel System.
DIAGNOSTIC GRIFOLS SA
210404
In Commercial Distribution

  • 08436583731215 ()
210404

  • Blood bank information system application software
Blood Typing Manager is a transfusion data manager software that aids in interfacing and managing data between immunohematology instruments, Blood Establishment Computer Software and Laboratory Information System. Blood Typing Manager is a stand-alone software specifically designed to aid in interfacing and managing data among immunohematology instruments, Blood Establishment Computer Software and Laboratory Information System as part of the DG Gel System.
DIAGNOSTIC GRIFOLS SA
210404
Not in Commercial Distribution

  • 08436583730980 ()
210404

  • Blood bank information system application software
StrokeSENS LVO is a radiological computer-aided triage and notification software indicated for use in the analysis of CTA head images. The device is intended to assist hospital networks and trained clinicians in workflow triage by flagging and communication of suspected positive findings of Large Vessel Occlusion (LVO) in head CTA images.
Circle Neurovascular Imaging Inc
v1.x
In Commercial Distribution

  • B926SSSX10 ()


  • CT system application software
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