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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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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
No Description
Edan Instruments, Inc.
ECG-Viewer
In Commercial Distribution

  • 06944413808157 ()


  • Electrocardiograph, professional, multichannel
No Description
Edan Instruments, Inc.
Smart ECG Net
In Commercial Distribution

  • 6944413808331 ()
  • 06944413808140 ()


  • Electrocardiograph, professional, multichannel
No Description
Edan Instruments, Inc.
Smart ECG Broker
In Commercial Distribution

  • 6944413808324 ()
  • 06944413808126 ()


  • Electrocardiograph, professional, multichannel
No Description
Edan Instruments, Inc.
Insight
In Commercial Distribution

  • 06944413808072 ()


  • Electrocardiograph, professional, multichannel
No Description
Edan Instruments, Inc.
Oximeter Viewer
In Commercial Distribution

  • 06944413807709 ()


  • Electrocardiograph, professional, multichannel
No Description
Edan Instruments, Inc.
Smart ECG Viewer
In Commercial Distribution

  • 06944413807693 ()
  • 06944413808065 ()


  • Electrocardiograph, professional, multichannel
StrokeSENS LVO is a radiological computer-aided triage and notification (CADt) 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 (L VO) in head CTA images. StrokeSENS LVO uses a software algorithm to identify suspected LVO findings. In the case of a suspected L VO, the system will send a notification to a pre-configured destination(s), notifying the clinicians of the existence of a suspected LVO that requires review. The notification system is intended to be used in parallel to the standard of care workflow to notify clinicians of the existence of the case earlier that they may have been notified as part of the standard of care workflow. Notifications may include a compressed preview of images. Notifications are meant for informational purposes only and are not intended for diagnostic use beyond notification. The StrokeSENS LVO device does not alter the original medical image and is not intended to be used as a diagnostic device. The results of StrokeSENS LVO are intended to be used in conjunction with other patient information and based on professional judgement, to assist with triage/ prioritization of medical images. Notified clinicians are responsible for viewing full images per standard of care.
Circle Cardiovascular Imaging Inc
v2.x
In Commercial Distribution



  • CT system application 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
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