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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 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 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 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
STANDARD BALLOON CATHETER SILICONE (6/Pk)
Gyrus ACMI, LLC
890923
Not in Commercial Distribution

  • 00821925022355 ()
  • 00821925040342 ()


  • Nasal/paranasal balloon catheter
Adson forceps are surgical instruments used for grasping and manipulating delicate tissues during surgical procedures, with 1x2 teeth and a length of 12.5cm. The teeth provide a secure grip, while the slim profile allows for precise control.
CONCISE ENTERPRISES
150302412
In Commercial Distribution

  • G2021503024120 ()
15-03024-12

  • Dressing/utility forceps, tweezers-like, single-use
Adson forceps are a type of surgical instrument commonly used in medical procedures. The forceps are named after Alfred Washington Adson, a prominent American surgeon who invented them in the early 20th century. The Adson forceps are specifically designed for delicate surgical procedures that require a precise grip and manipulation of small tissues, such as skin or blood vessels. They are fine-tipped and have a serrated pattern on the working end that provides a firm grip on the tissue being held. The forceps are made of high-quality stainless steel and are approximately 12cm in length. They feature a hinged design with a spring mechanism that allows the surgeon to easily manipulate the forceps with one hand. Overall, the Adson forceps are a valuable tool in any surgical setting and are commonly used in various procedures such as plastic surgery, dermatology, and ophthalmology. Their fine tips and delicate grip make them an ideal choice for precise and delicate surgical procedures.
CONCISE ENTERPRISES
150283012
In Commercial Distribution

  • G2021502830120 ()
15-02830-12

  • Dressing/utility forceps, tweezers-like, single-use
WILLIAMS MICROCLIP INSERTER
Gyrus ACMI, LLC
130830
In Commercial Distribution

  • 00821925016866 ()


  • Dressing/utility forceps, tweezers-like, single-use
VENTERA SINUS DILATION BALLOON 1-PACK
Smith & Nephew, Inc.
650-60100S
Not in Commercial Distribution

  • 00817470009729 ()
650-60100S

  • Nasal/paranasal balloon catheter
ECONO STERILE FN-PT SPLINT FCP 4 1/2 STER 25
SKLAR CORPORATION
96-2412A
In Commercial Distribution

  • 50649111487550 ()
  • 10649111487552 ()


  • Dressing/utility forceps, tweezers-like, single-use
ECONO STERILE FOERSTER SPG FCP CVD 9.5STER25
SKLAR CORPORATION
96-2534
In Commercial Distribution

  • 50649111478817 ()
  • 10649111478819 ()


  • Dressing/utility forceps, tweezers-like, single-use
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