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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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Tempo Insights - B553TEMPOINSIGHTS110

Tempo Insights™ is the healthcare provider-facing component of TempoSmart. Neither Tempo Insights nor TempoSmart is intended to replace the research, expertise, judgment, or treatment provided to patients by healthcare providers. TempoSmart™ is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. TempoSmart is intended to assist patients in managing their diabetes with guidance from their providers.
WELLDOC, INC.
v1.1
In Commercial Distribution

  • B553TEMPOINSIGHTS110 ()


  • Home pharmaceutical management support software

Tempo Insights - B553TEMPOINSIGHTS100

Tempo Insights™ is the healthcare provider-facing component of TempoSmart. Neither Tempo Insights nor TempoSmart is intended to replace the research, expertise, judgment, or treatment provided to patients by healthcare providers. TempoSmart™ is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. TempoSmart is intended to assist patients in managing their diabetes with guidance from their providers.
WELLDOC, INC.
v1.0
Not in Commercial Distribution

  • B553TEMPOINSIGHTS100 ()


  • Home pharmaceutical management support software

TempoSmart - B553TEMPOSMART110

TempoSmart™ is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. TempoSmart is intended to assist patients in managing their diabetes with guidance from their providers.
WELLDOC, INC.
v1.1
In Commercial Distribution

  • B553TEMPOSMART110 ()


  • Home pharmaceutical management support software

nuance audio - 08056262013229

No Description
LUXOTTICA GROUP SPA
WAW000001
In Commercial Distribution

  • 08056262013229 ()


  • Air-conduction hearing aid, spectacle

nuance audio - 08059820279921

No Description
LUXOTTICA GROUP SPA
AW5004656
In Commercial Distribution

  • 08059820279921 ()


  • Air-conduction hearing aid, spectacle

nuance audio - 08059820279914

No Description
LUXOTTICA GROUP SPA
AW5004556
In Commercial Distribution

  • 08059820279914 ()


  • Air-conduction hearing aid, spectacle

nuance audio - 08059820279907

No Description
LUXOTTICA GROUP SPA
AW5004456
In Commercial Distribution

  • 08059820279907 ()


  • Air-conduction hearing aid, spectacle

nuance audio - 08059820279860

No Description
LUXOTTICA GROUP SPA
AW5004356
In Commercial Distribution

  • 08059820279860 ()


  • Air-conduction hearing aid, spectacle

nuance audio - 08059820279792

No Description
LUXOTTICA GROUP SPA
AW5002648
In Commercial Distribution

  • 08059820279792 ()


  • Air-conduction hearing aid, spectacle

nuance audio - 08059820279785

No Description
LUXOTTICA GROUP SPA
AW5002548
In Commercial Distribution

  • 08059820279785 ()


  • Air-conduction hearing aid, spectacle
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