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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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No Description
SCC SOFT COMPUTER
1.0.0.19
In Commercial Distribution

  • 00810055814145 ()


  • Bedside information system application software
No Description
SCC SOFT COMPUTER
25.5.6.3
In Commercial Distribution

  • 00810055813667 ()


  • Blood bank information system application software
No Description
SCC SOFT COMPUTER
4.5.4.2
In Commercial Distribution

  • 00810055813650 ()


  • Blood bank information system application software
No Description
SCC SOFT COMPUTER
25.6.1.1
In Commercial Distribution

  • 00810055812837 ()


  • Blood bank information system application software
No Description
SCC SOFT COMPUTER
1.0.0.18
In Commercial Distribution

  • 00810055812257 ()


  • Bedside information system application software
No Description
SCC SOFT COMPUTER
25.5.6.2
In Commercial Distribution

  • 00810055810727 ()


  • Blood bank information system application software
The Fitbit Irregular Rhythm Notifications is a software-only mobile medical application that is intended to be used with compatible consumer wrist-worn products to analyze pulse rate data to identify episodes of irregular heart rhythms suggestive of atrial fibrillation (AFib) and provide a notification to the user. The Fitbit Irregular Rhythm Notifications is intended for over-the-counter (OTC) use. It is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the Fitbit Irregular Rhythm Notifications is intended to opportunistically surface a notification of possible AFib when sufficient data are available for analysis. These data are only captured when the user is still. Along with the user’s risk factors, the Fitbit Irregular Rhythm Notifications can be used to supplement the decision for AFib screening. The Fitbit Irregular Rhythm Notifications is not intended to replace traditional methods of diagnosis or treatment. The Fitbit Irregular Rhythm Notifications has not been tested for and is not intended for use in people under 22 years of age. It is also not intended for use in individuals previously diagnosed with AFib.
FITBIT, INC.
FB604
In Commercial Distribution

  • 00810038852720 ()
FB604

  • Cardiopulmonary physiological parameter analysis software
No Description
Naturalcycles Nordic AB
V5.4.0
In Commercial Distribution

  • 07350014630339 ()


  • Self-care monitoring/reporting software
No Description
Naturalcycles Nordic AB
V5.0
In Commercial Distribution

  • 07350014630285 ()


  • Self-care monitoring/reporting software
Package for 6-month subscription of Natural Cycles. Includes a Basal Body Thermometer and a subscription code for 6 months access to the app.
Naturalcycles Nordic AB
13
In Commercial Distribution

  • 07350014630131 ()


  • Self-care monitoring/reporting software
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