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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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Kit includes: Single Channel ECG Acquisition Module (DI no.: 07290110251062) for integration in other Medical Devices (GE Wuxi). Special edition for GE Health Care.
NORAV MEDICAL LTD.
ECGUSB1DEX Kit
In Commercial Distribution

  • 07290110255435 ()
ECGUSB1DEX-K-00-01

  • Electrocardiographic signal amplifier
Kit includes: Single Channel ECG Acquisition Module (DI no.: 07290110254292) for integration in other Medical Devices (GE Wuxi). Special edition for GE Health Care.
NORAV MEDICAL LTD.
ECGUSB1DEX Kit
In Commercial Distribution

  • 07290110251093 ()
ECGUSB1DEX-K-00-01

  • Electrocardiographic signal amplifier
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. Health Optimizer is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.
WELLDOC, INC.
v1.1
Not in Commercial Distribution

  • B553HLTHOPTIMIZER110 ()


  • 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. Health Optimizer is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.
WELLDOC, INC.
v1.0
Not in Commercial Distribution

  • B553HLTHOPTIMIZER100 ()


  • Home pharmaceutical management support software
Scale, Digital Home Health Model DHH-10 440lb (200kg) x 0.2lb (0.1kg) 300mm (L) x 360mm (W) x 8mm (H) includes (2) AAA batteries, tempered glass
Rice Lake Weighing Systems, Inc.
DHH-10
In Commercial Distribution

  • 00850042373262 ()
201124

  • Stand-on floor scale, electronic
The Neeva Baby Fetal Doppler is an ultrasonic Doppler that allows expectant mothers and health care professionals to retrieve and listen to the fetal heart
Sebe Inc
NB Fetal Doppler 3MHz
In Commercial Distribution

  • 00860005571932 ()


  • Foetal Doppler system
The Neeva Baby Fetal Doppler is an ultrasonic Doppler that allows expectant mothers and health care professionals to retrieve and listen to the fetal heart
Sebe Inc
NB Fetal Doppler 2MHz
In Commercial Distribution

  • 00860005571901 ()


  • Foetal Doppler system
A blood bag temperature monitor for use by health care providers to determine if blood or blood products have reached or exceeded the indication temperature.
Temptime Corporation
STV6
In Commercial Distribution

  • 10852282007157 ()
  • 00852282007150 ()
  • 20852282007154 ()
7206-50

  • Medical product temperature point indicator, thermochemical
A blood bag temperature monitor for use by health care providers to determine if blood or blood products have reached or exceeded the indication temperature.
Temptime Corporation
STV10
In Commercial Distribution

  • 20852282007147 ()
  • 10852282007140 ()
  • 00852282007143 ()
7201-50

  • Medical product temperature point indicator, thermochemical
ULTRASOUND GEL Water Soluble Acoustically correct Non-irritating Cardinal Health Ultrasound Gel is an acoustically correct, dye-free and greaseless echogenic medium used for all ultrasound procedures.
Cardinal Health 200, LLC
USG-5L
In Commercial Distribution

  • 50885380066045 ()
  • 10885380066047 ()
USG-5L

  • Skin topical coupling gel
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