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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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TempoSmart - B553TEMPOSMART100

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

  • B553TEMPOSMART100 ()


  • Home pharmaceutical management support software

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

Comfort Splint - D745COMSPL0

Device to alleviate pain caused by bruxing or clenching of teeth
Prismatik Dentalcraft, Inc
COMSPL
In Commercial Distribution

  • D745COMSPL0 ()
COMSPL

  • Mouthguard, reusable

Amplatz - 00827002574731

Amplatz Radiopaque TFE Sheath
COOK INCORPORATED
G57473
In Commercial Distribution

  • 00827002574731 ()
VS-300030-ARI-01

  • Non-vascular catheter introduction set

Amplatz - 00827002574724

Amplatz Radiopaque TFE Sheath
COOK INCORPORATED
G57472
In Commercial Distribution

  • 00827002574724 ()
VS-300016-ARI-01

  • Non-vascular catheter introduction set

Amplatz - 00827002574717

Amplatz Radiopaque TFE Sheath
COOK INCORPORATED
G57471
In Commercial Distribution

  • 00827002574717 ()
VS-240016-ARI-01

  • Non-vascular catheter introduction set

Amplatz - 00827002574700

Amplatz Radiopaque TFE Sheath
COOK INCORPORATED
G57470
In Commercial Distribution

  • 00827002574700 ()
VS-180016-ARI-01

  • Non-vascular catheter introduction set

Cook - 00827002574694

Clear Amplatz Sheath with Radiopaque Stripe
COOK INCORPORATED
G57469
In Commercial Distribution

  • 00827002574694 ()
CAS-300017-01

  • Non-vascular catheter introduction set
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