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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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The CEM Viewer for NAVIS-EX software (hereafter referred to as CEM Viewer) is used to view the examination data of the SPECULAR MICROSCOPE CEM-530 or use the data for follow-up within IMAGE FILING SOFTWARE NAVIS-EX. This function is added to the computer as a plug-in for NAVIS-EX. The examination data is displayed, analyzed, and used for follow-up. CEM Viewer can be used to display examination data on the Viewer screen or follow up data on the Follow-Up screen. The examination data is saved and managed within NAVIS-EX. The CEM Viewer data is imported to NAVIS-EX using separate software, Data Acquisition Service for NAVIS-EX.
NIDEK CO.,LTD.
1.1
In Commercial Distribution

  • 04987669101353 ()


  • Eye anterior segment analyser software
No Description
KONAN MEDICAL, INC.
Cellchek
Not in Commercial Distribution

  • 04582275250428 ()


  • Eye anterior segment analyser software
No Description
HICLUB, INC.
/
In Commercial Distribution

  • 04595318292019 ()


  • Sleep disorder interpretive software, patient-use
PeriWatch Surveillance is intended to be used as a complete Obstetrical Data Management System, which has the ability to record, store, and display data from fetal and maternal vital signs monitors. It manages patient information from the initial prenatal care to post-delivery discharge. It organizes clinical data that would normally be provided on paper records or other clinical systems and devices. The system also serves a a decision support tool and electronic medical record.
PERIGEN INC.
2020 Rev 1.0
In Commercial Distribution

  • 00860003483503 ()


  • Obstetrics information system application software
EndoTool IV is a glucose management software system used by healthcare professionals in all inpatient care settings for adult and pediatric patients aged two years and above who weigh 12 kgs. or more. EndoTool adjusts and maintains a patient’s glucose level within a configurable clinician-determined target range by recommending patient-specific intravenous insulin dosing, carbohydrate dosing for recovery or supplementation, and subcutaneous dosing for the transition from IV dosing. EndoTool IV logic is not a substitute for but rather an adjunct to clinical reasoning. No medical decision should be based solely on the recommended guidance provided by this software system.
MONARCH MEDICAL TECHNOLOGIES LLC
3.1
In Commercial Distribution

  • 00860003340639 ()


  • Infusion pump medication-dosage application software
EndoTool SubQ is a software application for use by trained healthcare professionals to calculate and recommend an individual patient’s next dose of insulin to be administered subcutaneously to manage blood glucose levels in patients with hyperglycemia including adult and pediatric patients (age 2 years and above and 12 kg or more). The software is designed to recommend the insulin dose(s) and when indicated a carbohydrate dose based on the prescribing healthcare Provider’s nutritional regimen, insulin regimen, target glucose range, and patient specific characteristics.
MONARCH MEDICAL TECHNOLOGIES LLC
SubQ 2.0
In Commercial Distribution



  • Infusion pump medication-dosage application software
EndoTool is a glucose management software system, designed for use by healthcare professionals in all patient care settings to recommend intravenous and subcutaneous transition dosing, as well as carbohydrates. Evaluating current and cumulative glucose levels, the software adjusts and maintains the glucose level within a configurable clinician-determined target range. The system is indicated for use in adult and pediatric patients ages 2 years and above, who weigh 12 kgs. or more. EndoTool logic is not a substitute for, but rather an adjunct to clinical reasoning. No medical decision should be based solely on the recommended guidance provided by this software system.
MONARCH MEDICAL TECHNOLOGIES LLC
EndoTool IV 2.0
In Commercial Distribution



  • Infusion pump medication-dosage application software
EndoTool is a glucose management software system, designed for use by healthcare professionals in all patient care settings to recommend intravenous and subcutaneous transition dosing, as well as carbohydrates. Evaluating current and cumulative glucose levels, the software adjusts and maintains the glucose level within a configurable clinician-determined target range. The system is indicated for use in adult and pediatric patients ages 2 years and above, who weigh 12 kgs. or more. EndoTool logic is not a substitute for, but rather an adjunct to clinical reasoning. No medical decision should be based solely on the recommended guidance provided by this software system.
MONARCH MEDICAL TECHNOLOGIES LLC
None
In Commercial Distribution

  • 00860003340608 ()


  • Infusion pump medication-dosage application software
Cassie is a Software as a Medical Device (SaMD) that automatically analyzes, displays, and summarizes Photoplethysmogram (PPG) data collected during sleep using compatible devices. Cassie is intended for use by and by order of a healthcare professional to aid in the diagnosis of sleep disorders in adults. The Cassie output may be displayed and edited by a qualified healthcare professional. The Cassie output is not intended to be interpreted or clinical action taken without consultation of a qualified healthcare professional.
Tatch Inc.
0.9.0
In Commercial Distribution

  • 00860007837036 ()


  • Sleep disorder interpretive software, professional-only
TRAQinform IQ is a software tool used to aid in evaluation and information management of digital medical images by trained medical professionals including, but not limited to, radiologists, oncologists, nuclear medicine physicians, medical imaging technologists, dosimetrists and physicists. The medical modalities of these medical images include DICOM CT and PET as supported by ACR/NEMA DICOM 3.0. TRAQinform IQ assists in the following indications: • Receive, store, retrieve, display and process digital medical images. • Create, display and print reports from those images. • Provide medical professionals with the ability to display, register, and fuse medical images. • Identify Regions of Interest (ROIs) and perform ROI contouring allowing quantitative/statistical analysis of full or partial body scans. • Evaluate quantitative change in ROIs (total or partial body; individual ROI within individual) with 3D interactive rendering of images with highlighted ROIs
Aiq Global, Inc.
1
In Commercial Distribution

  • 00860007104909 ()


  • Radiology information system application software
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