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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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Non Contact Infrared Body Thermometer
Hetaida Technology Co., Ltd
HTD8816C
Not in Commercial Distribution

  • 16436200289883 ()
  • 06436200289886 ()
  • 26436200289880 ()


  • Infrared patient thermometer, skin
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
DCS 010 Drainage Collection System
Irras USA, Inc.
DCS 010
In Commercial Distribution

  • 10868643000477 ()
  • 00868643000470 ()
DCS 010

  • Intracerebral sensor catheter, short-term
  • Intracranial pressure monitor
DispenSecur is a device intended for medical purposes to provide alerts and controlled patient access to medication based on dosing schedules predetermined by a healthcare provider. The device may be used with either liquid or solid dosage forms of one medication type. The device is not intended to manage multiple medications.
Verinetics Inc
1
In Commercial Distribution

  • 00860011977513 ()


  • Personal pill dose dispenser, electric
The EmbryoScope time-lapse incubator (Version D) provides an environment with controlled temperature, CO2 (and other gases) for the development of embryos. This model has an integrated inverted microscope and imaging system for embryo viewing. Device use is limited to five days (120 hr) covering the time from post-fertilization to day 5 of development.
Vitrolife A/S
ESD20000
In Commercial Distribution

  • 05712714603013 ()
ESD20000

  • Assisted reproduction incubator/microscope camera system
The VYAFUSER™ Pump is an ambulatory infusion pump intended for the subcutaneous delivery of VYALEV
Phillips-Medisize A/S
VYAFUSER PUMP KIT US/PR A
In Commercial Distribution

  • 05713495001043 ()
  • 05713495000152 ()
  • 05713495000169 ()

  • Length: 6.7 Inch
  • Width: 3 Inch
  • Depth: 1.3 Inch
  • Weight: 285 Gram
2089870410

  • Ambulatory syringe pump
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
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
No Description
FUJIFILM NEW DEVELOPMENT U.S.A., INC.
EL-580FN
Not in Commercial Distribution

  • 00856853006016 ()


  • Rigid video laparoscope
The ColorBurst is a flash stimulator component that can only be used as part of the D310 & D315.
DIAGNOSYS LLC
D213
In Commercial Distribution

  • 00855730007399 ()


  • Electroretinograph
The LCD Monitor is a pattern stimulator component that can only be used as part of the D310 & D315.
DIAGNOSYS LLC
D359
In Commercial Distribution

  • 00855730007382 ()


  • Electroretinograph
The ColorFlash is a flash stimulator component that can only be used as part of the D310 & D315.
DIAGNOSYS LLC
D382
In Commercial Distribution

  • 00855730007375 ()


  • Electroretinograph
The EER is an electrical stimulator component that can only be used as part of the D310 & D315.
DIAGNOSYS LLC
D366
In Commercial Distribution

  • 00855730007368 ()


  • Electroretinograph
The Envoy Monitor is a pattern stimulator component that can only be used as part of the D310 & D315.
DIAGNOSYS LLC
D352
In Commercial Distribution

  • 00855730007351 ()


  • Electroretinograph
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