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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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Bluestar Rx - B553202004RX0

BlueStar® Rx 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. BlueStar Rx is intended to assist patients in managing their diabetes with guidance from their providers. BlueStar® Rx is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. BlueStar Rx is intended to provide secure capture, storage, and transmission of glucose data as well as information to aid in diabetes self-management. BlueStar Rx analyzes, and reports glucose test results and supports medication adherence. In addition, BlueStar Rx provides coaching messages (motivational, behavioral, and educational) based on real-time glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information. BlueStar is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.
WELLDOC, INC.
v7.X
In Commercial Distribution

  • B553202004RX0 ()


  • Home pharmaceutical management support software

Bluestar - B553202003OTC0

BlueStar 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. BlueStar is intended to assist patients in managing their diabetes with guidance from their providers BlueStar® is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. BlueStar is intended to provide secure capture, storage, and transmission of glucose data as well as information to aid in diabetes self-management. BlueStar analyzes, and reports glucose test results and supports medication adherence. In addition, BlueStar provides coaching messages (motivational, behavioral, and educational) based on real-time glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information. BlueStar is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.
WELLDOC, INC.
v7.X
In Commercial Distribution

  • B553202003OTC0 ()


  • Home pharmaceutical management support software

Bluestar Rx - B553202002RX0

BlueStar® Rx 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. BlueStar Rx is intended to assist patients in managing their diabetes with guidance from their providers. BlueStar® Rx is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. BlueStar Rx is intended to provide secure capture, storage, and transmission of glucose data as well as information to aid in diabetes self-management. BlueStar Rx analyzes, and reports glucose test results and supports medication adherence. In addition, BlueStar Rx provides coaching messages (motivational, behavioral, and educational) based on real-time glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information. BlueStar is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.
WELLDOC, INC.
v7.X
In Commercial Distribution

  • B553202002RX0 ()


  • Home pharmaceutical management support software

Bluestar - B553202001OTC0

BlueStar 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. BlueStar is intended to assist patients in managing their diabetes with guidance from their providers BlueStar® is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. BlueStar is intended to provide secure capture, storage, and transmission of glucose data as well as information to aid in diabetes self-management. BlueStar analyzes, and reports glucose test results and supports medication adherence. In addition, BlueStar provides coaching messages (motivational, behavioral, and educational) based on real-time glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information. BlueStar is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.
WELLDOC, INC.
v7.X
In Commercial Distribution

  • B553202001OTC0 ()


  • Home pharmaceutical management support software

RELIEVA SPINPLUS NAV - 10705031241008

RELIEVA SPINPLUS NAV BALLOON SINUPLASTY SYSTEM, 5X16MM, 3 GUIDE KIT
ACCLARENT, INC.
RSP0516MFSN
In Commercial Distribution

  • 20705031241005 ()
  • 10705031241008 ()
RSP0516MFSN

  • Nasal/paranasal balloon catheter

RELIEVA SPINPLUS NAV - 10705031241015

RELIEVA SPINPLUS NAV BALLOON SINUPLASTY SYSTEM, 6X16MM, 3 GUIDE KIT
ACCLARENT, INC.
RSP0616MFSN
In Commercial Distribution

  • 20705031241012 ()
  • 10705031241015 ()
RSP0616MFSN

  • Nasal/paranasal balloon catheter

EXEL 5ML CLEAR HLDR, Non-Sterile - 00020221265316

EXEL 5ML CLEAR HLDR, Non-Sterile 1,000PCS/DOUBLE BAG PER CASE
Exel International
26531
In Commercial Distribution

  • 10020221265313 ()
  • 00020221265316 ()
  • 20020221265310 ()
26531

  • Blood collection tube holder/needle

EXEL Luer Holder - 00020221265309

Luer Holder, Bulk, Non-Sterile
Exel International
26530
In Commercial Distribution

  • 00020221265309 ()
  • 20020221265303 ()
  • 10020221265306 ()
26530

  • Blood collection tube holder/needle

ULTRAFLO-V - 10857182006224

SAFETY BLOOD COLLECTION SET 22GX1.25"
Innovative Medical Technologies, Inc.
608
In Commercial Distribution

  • 00857182006227 ()
  • 10857182006224 ()
608

  • Blood collection tube holder/needle

Insulia - 03760261310085

No Description
VOLUNTIS
Redwing A_1.6_US
In Commercial Distribution

  • 03760261310085 ()


  • Home pharmaceutical management support software
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