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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™ 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.
2.X
In Commercial Distribution

  • B553202174RX0 ()


  • Home pharmaceutical management support software
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.
2.X
In Commercial Distribution

  • B553202173OTC0 ()


  • Home pharmaceutical management support software
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.
2.X
In Commercial Distribution

  • B553202172RX0 ()


  • Home pharmaceutical management support software
Health Optimizer® is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. Health Optimizer is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. Health Optimizer analyzes and reports blood glucose test results and supports medication adherence. In addition, Health Optimizer provides coaching messages (motivational, behavioral, and educational) based on real-time blood 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.
WELLDOC, INC.
2.X
In Commercial Distribution

  • B553202193OTC0 ()


  • Home pharmaceutical management support software
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.
2.X
In Commercial Distribution

  • B553202171OTC0 ()


  • Home pharmaceutical management support software
MRI CONDITIONAL FIBER OPTIC MIL 2 LARYNGOSCOPE BLADE
NOVAMED-USA INC.
15-MRI-MIL 2
In Commercial Distribution

  • 00817499021030 ()


  • Laryngoscope blade, reusable
MRI CONDITIONAL FIBER OPTIC ENGLISH MAC 2 LARYNGOSCOPE BLADE
NOVAMED-USA INC.
15-MRI-MAC 2
In Commercial Distribution

  • 00817499020972 ()


  • Laryngoscope blade, reusable
SINGLE USE FO HYBRID SS WITH ACRYLIC FO BUNDLE MIL 2 LARYNGOSCOPE BLADE
NOVAMED-USA INC.
16-300FOMD-MIL 2
In Commercial Distribution

  • 10817499020818 ()
  • 00817499020811 ()


  • Laryngoscope blade, single-use
SINGLE USE FO HYBRID SS WITH ACRYLIC FO BUNDLE MAC 2 LARYNGOSCOPE BLADE
NOVAMED-USA INC.
16-100FOMD-MAC 2
In Commercial Distribution

  • 10817499020757 ()
  • 00817499020750 ()


  • Laryngoscope blade, single-use
Super Jennie menstrual cup is a soft device made of medical grade silicone. It is to be placed by the user into the vagina to collect blood during menstruation.
Anigan Inc.
Pink 2
In Commercial Distribution

  • 00817453021168 ()
SJ004

  • Menstrual cup, non-latex, reusable
EvaCup menstrual cup is a soft device made of medical grade silicone. It is to be placed by the user into the vagina to collect blood during menstruation.
Anigan Inc.
Pink 2
In Commercial Distribution

  • 00817453020833 ()
EVA002

  • Menstrual cup, non-latex, reusable
Super Jennie menstrual cup is a soft device made of medical grade silicone. It is to be placed by the user into the vagina to collect blood during menstruation.
Anigan Inc.
Blue 2
In Commercial Distribution

  • 00817453020437 ()
SJ005

  • Menstrual cup, non-latex, reusable
Super Jennie menstrual cup is a soft device made of medical grade silicone. It is to be placed by the user into the vagina to collect blood during menstruation.
Anigan Inc.
Teal 2
In Commercial Distribution

  • 00817453020413 ()
SJ002

  • Menstrual cup, non-latex, reusable
Wedelstadt #1/2
Zoll-Dental
OPAF-Wed1/2
In Commercial Distribution

  • 00840105206118 ()


  • Margin finishing dental file/rasp, reusable
1 1/2" Exam Mirror (Cone & Socket)
Zoll-Dental
MIRROR-1-1/2
In Commercial Distribution

  • 00840105205791 ()


  • Dental mirror, reusable
1/2
Zoll-Dental
GAUZE-1/2
In Commercial Distribution

  • 00840105205470 ()


  • Gauze packer
Orban #1/2
Zoll-Dental
GK-Orban-1/2
In Commercial Distribution

  • 00840105205432 ()


  • Periodontal knife
ASL-QC 1/2 (Satin Finish)
Zoll-Dental
CUREASL-QC1/2
In Commercial Distribution

  • 00840105201533 ()


  • Dental elevator, sinus lift
Composite #1/2 Hollenback Carver
Zoll-Dental
COMP-HOL1/2
In Commercial Distribution

  • 00840105201229 ()


  • Dental spatula, reusable
Composite Black 1/2 Plugger
Zoll-Dental
COMP-BLK1/2
In Commercial Distribution

  • 00840105201151 ()


  • Dental spatula, reusable
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