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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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Configurable software for managing automated blood test results.
Rubin & Poor, Inc.
CTS 1.4A
In Commercial Distribution

  • 00860010612828 ()
3

  • Blood bank information system application software
Configurable software for managing manually entered blood test results.
Rubin & Poor, Inc.
MBC 1.0B
In Commercial Distribution

  • 00860010612811 ()
2

  • Blood bank information system application software
Configurable software for managing automated blood test results.
Rubin & Poor, Inc.
MBC 1.0B
In Commercial Distribution

  • 00860010612804 ()
1

  • Blood bank information system application software
Vision Orthodontic Planning Device
Softsmile, Inc.
Vision 1
In Commercial Distribution

  • 00860009273702 ()


  • CAD/CAM software
No Description
Blood Bank Computer System
5.0
In Commercial Distribution

  • 00860009119482 ()


  • Blood bank information system application software
No Description
Blood Bank Computer System
5.0
In Commercial Distribution

  • 00860009119475 ()


  • Blood bank information system application software
No Description
Blood Bank Computer System
1.0.0
In Commercial Distribution

  • 00860009119468 ()


  • Blood bank information system application software
No Description
Blood Bank Computer System
1.0.0
In Commercial Distribution

  • 00860009119451 ()


  • Blood bank information system application software
ABO QuickPass is a software application intended to allow donors to complete Computer Assisted Self Interviews (CASI) and computer assisted blood donor registrations. ABO QuickPass works in tandem with compatible blood bank systems to identify repeat donors, retrieve the donor’s donation eligibility, and retrieve the donor history questionnaire appropriate for the donor and intended donation. Upon completion of ABO QuickPass all information which is entered by the donor is transferred to compatible blood bank systems. CASIs can be completed using the Internet via the ABO QuickPass web portal or at the donor site via the ABO QuickPass kiosk. CASIs which are completed via the web portal produce an encrypted barcode, which can be decrypted and imported on the day of donation into the ABO QuickPass kiosk for transfer of question responses to the facilities compatible blood bank system
Blood Bank Computer System
1.0.0
In Commercial Distribution

  • 00860009119444 ()


  • Blood bank information system application software
No Description
Blood Bank Computer System
1.0.0
In Commercial Distribution

  • 00860009119437 ()


  • Blood bank information system application software
No Description
Blood Bank Computer System
6.0
In Commercial Distribution

  • 00860009119420 ()


  • Blood bank information system application software
No Description
Blood Bank Computer System
2.0.0
In Commercial Distribution

  • 00860009119406 ()


  • Blood bank information system application software
No Description
VETERANS AFFAIRS, UNITED STATES DEPARTMENT OF
VBECS 2.4.0
In Commercial Distribution

  • 00860271000952 ()


  • Blood bank information system application software
No Description
VETERANS AFFAIRS, UNITED STATES DEPARTMENT OF
VBECS 2.3.4
Not in Commercial Distribution

  • 00860271000945 ()


  • Blood bank information system application software
No Description
VETERANS AFFAIRS, UNITED STATES DEPARTMENT OF
VBECS 2.3.3
Not in Commercial Distribution

  • 00860271000938 ()


  • Blood bank information system application software
No Description
VETERANS AFFAIRS, UNITED STATES DEPARTMENT OF
VBECS 2.3.2
Not in Commercial Distribution

  • 00860271000921 ()


  • Blood bank information system application software
No Description
VETERANS AFFAIRS, UNITED STATES DEPARTMENT OF
VBECS 2.3.1
Not in Commercial Distribution

  • 00860271000914 ()


  • Blood bank information system application software
No Description
VETERANS AFFAIRS, UNITED STATES DEPARTMENT OF
VBECS 2.3.0
Not in Commercial Distribution

  • 00860271000907 ()


  • Blood bank information system application software
Lattice MediCopia for Specimen Collection, Transfusion Administration, Breast Milk and Anatomic Pathology.
Lattice Incorporated
4.x.x
In Commercial Distribution

  • 00860014128905 ()


  • Blood bank information system application software
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
ClearRead Xray Pneumothorax on Docker Platform
Riverain Technologies, Inc.
1.1.1
In Commercial Distribution

  • M722XD22145P212210 ()


  • Radiological PACS software
ClearRead Xray Console Pneumothorax
Riverain Technologies, Inc.
2.0.0
In Commercial Distribution

  • M722XC25114P250640 ()


  • Radiological PACS software
ClearRead Xray Console Pneumothorax
Riverain Technologies, Inc.
2.0.0
In Commercial Distribution

  • M722XC25064P250640 ()


  • Radiological PACS software
ClearRead Xray Server Pneumothorax
Riverain Technologies, Inc.
2.0.0
In Commercial Distribution

  • M722X25064P250640 ()


  • Radiological PACS software
ClearRead Xray Docker Pneumothorax
Riverain Technologies, Inc.
2.0.0
In Commercial Distribution

  • M722XD25114P250640 ()


  • Radiological PACS software
ClearRead Xray Docker Pneumothorax
Riverain Technologies, Inc.
2.0.0
In Commercial Distribution

  • M722XD25064P250640 ()


  • Radiological PACS software
ClearRead Xray Pneumothorax on Docker Platform
Riverain Technologies, Inc.
1.1.1
In Commercial Distribution

  • M722XD24079P212210 ()


  • Radiological PACS software
ClearRead Xray Pneumothorax on Console Platform
Riverain Technologies, Inc.
1.1.1
In Commercial Distribution

  • M722XC22145P212210 ()


  • Radiological PACS software
ClearRead Xray Server Pneumothorax
Riverain Technologies, Inc.
2.0.0
In Commercial Distribution

  • M722X25122P250640 ()


  • Radiological PACS software
ClearRead Xray Pneumothorax on Xray Platform
Riverain Technologies, Inc.
1.1.1
In Commercial Distribution

  • M722X22145P212210 ()


  • Radiological PACS software
The Liberty SRIMPORT software is an interface that is part of the SRIMPORT functionality to import data through a file based transmission. Its intended use is to import results from laboratory instruments, typically chemistry and special chemistry analysers. The interface module contains no interpretation algorithms and serves as a library functions to consolidate pre-determined results from external instruments. The Liberty SRIMPORT Software's indicated use is in the Blood Bank, Donor Centre and Plasma Testing Laboratories as well as Clinical Diagnostic and Screening Laboratories. It may be applied to a group of laboratory instruments that export test results to another device.
BIOMEDICAL DATA SOLUTIONS LIMITED
3.1
In Commercial Distribution

  • 05060496770059 ()


  • Blood bank information system application software
Sanguin Aurora 2.0 is indicated for use in Clinical Diagnostic Laboratories, Blood Bank and Blood Establishments where it captures test and result data from laboratory equipment. It can be applied to single tests or a panel of tests that are used to screen blood donation (whole blood or plasma) as a pre-requisite to transfusion. Typically these tests would include markers such as Hepatitis Markers and HIV and may include non-viral testing such as ABO and Rhesus confirmation of donors, patient typing and antibody screening.
BIOMEDICAL DATA SOLUTIONS LIMITED
2.0
In Commercial Distribution

  • 05060496770035 ()


  • Blood bank information system application software
No Description
EPIC SYSTEMS CORPORATION
4
In Commercial Distribution

  • 00850053416002 ()


  • Blood bank information system application software
InferRead CT Stroke.AI is a radiological computer aided triage and notification software for use in the analysis of non-enhanced head CT images. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging suspected positive findings of intracranial hemorrhage (ICH).
Infervision US Inc
1.1.0.0
In Commercial Distribution

  • 00850003095011 ()


  • Diagnostic x-ray digital imaging system workstation
  • X-ray image interpretive software
Clue Birth Control is a feature of the Clue period tracker mobile application. Clue Birth Control’s proprietary algorithm uses period start date information entered by the user to provide predictions of “high risk days” and “low risk days” for becoming pregnant based on a Fertility Awareness Based Method (FABM) of contraception. Identification of high risk days allows the user to determine the days on which her risk of conception is highest, and then make choices about either abstaining from sex or using a barrier method of contraception to prevent pregnancy. To use Clue Birth Control, users go through an onboarding process from within the Clue app, during which they are asked to provide information that will determine whether they meet the Clue Birth Control use criteria. Clue Birth Control can only be used by women who are between 18 and 45 years old and their last 12 cycles were between 20 and 40 days and the difference between the lengths of the shortest and longest cycles is less than or equal to 9 days. In addition, users must have had at least three cycles (four periods) after stopping hormonal birth control (HBC) or since the end of a pregnancy.
BioWink GmbH
1
In Commercial Distribution

  • 04260749840008 ()


  • Self-care monitoring/reporting software
The Progressive Orthodontics App is an orthodontic appliance design and treatment simulation software. This software is for use by dental professionals in a healthcare facility to assist in diagnosis and design solutions for patients. Digital scans (3D) of a patient’s dentition can be loaded into the software and the dental professional can then review different treatment plans and simulations for each individual patient and decide on the most appropriate treatment.
PROGRESSIVE AMERICA, INC.
0.9.6
In Commercial Distribution

  • D16409625 ()


  • CAD/CAM software
OSTEOTOME, STRAIGHT, Ø 3 MM, 15,5CM
BMT Medizintechnik GmbH
FL-295
In Commercial Distribution

  • 04251725219826 ()
FL-295

  • Dental osteotome
The Progressive Orthodontics App is an orthodontic appliance design and treatment simulation software. This software is for use by dental professionals in a healthcare facility to assist in diagnosis and design solutions for patients. Digital scans (3D) of a patient’s dentition can be loaded into the software and the dental professional can then review different treatment plans and simulations for each individual patient and decide on the most appropriate treatment.
PROGRESSIVE AMERICA, INC.
2.0
In Commercial Distribution

  • D16420251 ()


  • CAD/CAM software
autoclavable accessories for the DEXTER ENDOSCOPE ARM
Aktormed GmbH
222590
In Commercial Distribution

  • 04260463845907 ()
222590

  • Surgical camera holder
autoclavable accessories for the DEXTER ENDOSCOPE ARM
Aktormed GmbH
212518
In Commercial Distribution

  • 04260463845181 ()
212518

  • Surgical camera holder
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