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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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SPEAKING BLOOD PRESSURE MONITOR - upper arm automatic-inflation electronic Sphygmomanometer, portable.
BEURER NORTH AMERICA, L.P.
SBM52
In Commercial Distribution

  • 10853879007925 ()
  • 00853879007928 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
The BrainPort® V100 is an oral electronic vision aid that provides electrotactile stimulation to aid profoundly blind patients in orientation, mobility, and object recognition as an adjunctive device to other assistive methods such as the white cane or a guide dog. It translates digital information from a video camera to gentle electrical stimulation patterns on the surface of the tongue.
WICAB, INC
V100
In Commercial Distribution

  • 00862378000309 ()
DR-001062

  • Video-camera translingual electrical stimulation system
Collimator, Manual Certified, 150kVp, LED 25W
COLLIMARE, LLC
CML-150-0001-C
In Commercial Distribution

  • 00862005000306 ()


  • Manual-aperture-control diagnostic x-ray system collimator, non-motorized
The silicon patch is a small, thin layer of soft silicon used for the adherence of specific sensor.
VIVALNK, INC.
A13
In Commercial Distribution

  • 00865064000188 ()


  • Dressing-fixation skin adhesive tape, silicone
The wireless Enfasmart FeverSense Continuous Monitoring Thermometer is a non-invasive and re-usable electronic device for home use. This product is intended for non-urgent ambulatory continuous armpit body temperature monitoring from ages 29 days and older.
VIVALNK, INC.
VV220
In Commercial Distribution

  • 00865064000164 ()


  • Wireless patient thermometer, reusable
VV330 Continuous ECG Platform is a wireless recording system intended for use by healthcare professionals for record and display of physiological data within healthcare settings or at home. This includes electrocardiogram (ECG), accelerometer data, R-R Interval and heart rate. Data is transmitted wirelessly to a separate location (such as a mobile phone) for storage and display. The VV330 Continuous ECG Platform can be configured by Authorized Persons to modify or merge or ignore any of the operational alerts, but not to set new alerts related to physiological data. The device is not intended to be used on critical care patients and is intended to supplement vital signs recording for later viewing by healthcare professionals, not to replace current standards of care. The device is an ambulatory, continuous recording system intended for use on general care patients and on patients who are 18 years of age or older.
VIVALNK, INC.
VV330
In Commercial Distribution

  • 00865064000157 ()


  • Electrocardiography telemetric monitoring system
The silicon patch is a small, thin layer of soft silicon used for the adherence of specific sensor.
VIVALNK, INC.
VV200A
In Commercial Distribution

  • 00865064000133 ()


  • Dressing-fixation skin adhesive tape, silicone
The silicon patch is a small, thin layer of soft silicon used for the adherence of specific sensor.
VIVALNK, INC.
VV220A
In Commercial Distribution

  • 00865064000126 ()


  • Dressing-fixation skin adhesive tape, silicone
The wireless Fever Scout™ Continuous Monitoring thermometer is a non-invasive and re-usable electronic device for home use. This product is intended for non-urgent ambulatory continuous armpit body temperature monitoring from ages 29 days and older.
VIVALNK, INC.
VV200
In Commercial Distribution

  • 00865064000119 ()


  • Wireless patient thermometer, reusable
Upper Arm Blood Pressure Monitor
BEURER NORTH AMERICA, L.P.
SBM46
In Commercial Distribution

  • 00852547004962 ()
  • 10852547004969 ()
Type: SBM46/1

  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
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