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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 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
Conifer Connect includes Conifer Connect Diabetes and Conifer Connect Diabetes Rx, which 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. Conifer Connect Diabetes and Conifer Connect Diabetes Rx are intended to assist patients in managing their diabetes with guidance from their providers. Conifer Connect Diabetes Rx requires a prescription.
WELLDOC, INC.
v1.X
In Commercial Distribution

  • B552202153OTC0 ()


  • Home pharmaceutical management support software
BLOOD COLLECTION HOLDER
HENRY SCHEIN, INC.
5702069
In Commercial Distribution

  • 20304040132382 ()
  • 10304040132385 ()
  • 00304040132388 ()
5702069

  • Blood collection tube holder/needle
SAFETY BLOOD COLLECITON NEEDLE
Jiangsu Micsafe Medical Tehcnology Co.,LTD.
1
In Commercial Distribution

  • 26971911292564 ()
  • 16971911292567 ()


  • Blood collection tube holder/needle
BLOOD COLLECTION NEEDLE 21Gx1 1/2
Jiangsu Micsafe Medical Tehcnology Co.,LTD.
1
In Commercial Distribution

  • 26971911292557 ()
  • 16971911292550 ()


  • Blood collection tube holder/needle
Safety Blood Collection Needle
Jiangsu Caina Medical Co.,Ltd
22Gx1 1/4"
In Commercial Distribution

  • 26971564462321 ()
  • 16971564462324 ()
BC062230-W

  • Blood collection tube holder/needle
Safety Blood Collection Needle
Jiangsu Caina Medical Co.,Ltd
21Gx1 1/4"
In Commercial Distribution

  • 26971564462314 ()
  • 16971564462317 ()
BC062130-W

  • Blood collection tube holder/needle
ONE-CARE Safety Blood Collection Needles 20G x 1 1/4'' with Holders, Yellow, 100/bx, 5bx/cs
MediVena, LLC
5022-H ONE-CARE Safety Blood Collection Needles 20G x 1 1/4'' with Holders
In Commercial Distribution

  • 00810008212950 ()
  • 00810008212967 ()
  • 00810008212974 ()

  • Needle Gauge: 20 Gauge
  • Length: 1.25 Inch
5022-H

  • Blood collection tube holder/needle
ONE-CARE Safety Blood Collection Needles 21G x 1 1/4'' with Holders, Green, 100/bx, 5bx/cs
MediVena, LLC
5021-H ONE-CARE Safety Blood Collection Needles 21G x 1 1/4'' with Holders
In Commercial Distribution

  • 00810008212936 ()
  • 00810008212929 ()
  • 00810008212943 ()

  • Needle Gauge: 21 Gauge
  • Length: 1.25 Inch
5021-H

  • Blood collection tube holder/needle
ONE-CARE Safety Blood Collection Needles 22G x 1 1/4'' with Holders, Black, 100/bx, 5bx/cs
MediVena, LLC
5020-H ONE-CARE Safety Blood Collection Needles 22G x 1 1/4'' with Holders
In Commercial Distribution

  • 00810008212905 ()
  • 00810008212899 ()
  • 00810008212912 ()

  • Needle Gauge: 22 Gauge
  • Length: 1.25 Inch
5020-H

  • Blood collection tube holder/needle
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