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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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Body-worn Hearing Aid
Zhongshan Tianle Hearing Technology Co., Ltd.
HA-98M
In Commercial Distribution

  • 06937572804429 ()


  • Air-conduction hearing aid, wearable case
Body-worn Hearing Aid
Zhongshan Tianle Hearing Technology Co., Ltd.
HA-96M
In Commercial Distribution

  • 06937572804412 ()


  • Air-conduction hearing aid, wearable case
Body-worn Hearing Aid
Zhongshan Tianle Hearing Technology Co., Ltd.
HA-95M
In Commercial Distribution

  • 06937572804405 ()


  • Air-conduction hearing aid, wearable case
Body-worn Hearing Aid
Zhongshan Tianle Hearing Technology Co., Ltd.
HA-93M
In Commercial Distribution

  • 06937572804399 ()


  • Air-conduction hearing aid, wearable case
ImmuLINK is middleware software that allows the user to link the application software database on automated (and/or semi-automated) blood bank instruments; the user may also link the instrument database(s) with the user’s Laboratory Information System (LIS). ImmuLINK is software designed to provide an interface between the user, blood bank instruments, and Blood Establishment Computer. ImmuLINK allows integration of sample, donor, or patient data that has been collected from multiple sources and provides data management tools to create customizable reports from the diverse data.
IMMUCOR, INC.
0030311
In Commercial Distribution

  • 10888234002475 ()


  • Laboratory instrument/analyser application software IVD
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
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
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