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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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1BYONE - 00863696000309

Arm blood pressure monitor
1BYONEPRODUCTS INC.
TMB-1585
In Commercial Distribution

  • 00863696000309 ()
  • 00863696000316 ()
  • 10863696000306 ()


  • Telemetric sphygmomanometer

T.O.V.A. - 00862290000333

The Test of Variables of Attention (T.O.V.A.) kit contains the hardware and software necessary to install and administer the T.O.V.A. continuous performance test. The T.O.V.A. provides healthcare professionals with objective measurements of attention and inhibitory control. The visual T.O.V.A. aids in the assessment of, and evaluation of treatment for, attention deficits, including attention-deficit/hyperactivity disorder (ADHD). The auditory T.O.V.A. aids in the assessment of attention deficits, including ADHD. T.O.V.A. results should only be interpreted by qualified professionals.
TOVA COMPANY, THE
Kit
In Commercial Distribution

  • 00862290000333 ()


  • Cognitive assessment software

T.O.V.A. - 00862290000326

The Test of Variables of Attention (T.O.V.A.) software is a computerized assessment of attention and inhibitory control that runs on most Windows and Mac-based computers. The T.O.V.A. provides healthcare professionals with objective measurements of attention and inhibitory control. The visual T.O.V.A. aids in the assessment of, and evaluation of treatment for, attention deficits, including attention-deficit/hyperactivity disorder (ADHD). The auditory T.O.V.A. aids in the assessment of attention deficits, including ADHD. T.O.V.A. results should only be interpreted by qualified professionals.
TOVA COMPANY, THE
Software
In Commercial Distribution

  • 00862290000326 ()


  • Cognitive assessment software

T.O.V.A. - 00862290000319

The T.O.V.A. microswitch precisely and accurately measures a subject's responses to the Test of Variables of Attention (T.O.V.A.), a computerized assessment of attention and inhibitory control. The T.O.V.A. provides healthcare professionals with objective measurements of attention and inhibitory control. The visual T.O.V.A. aids in the assessment of, and evaluation of treatment for, attention deficits, including attention-deficit/hyperactivity disorder (ADHD). The auditory T.O.V.A. aids in the assessment of attention deficits, including ADHD. T.O.V.A. results should only be interpreted by qualified professionals.
TOVA COMPANY, THE
Microswitch
In Commercial Distribution

  • 00862290000319 ()


  • Cognitive assessment software

T.O.V.A. - 00862290000302

The Test of Variables of Attention (T.O.V.A.) USB Device is a USB-peripheral that precisely and accurate records and securely stores a subject's responses to the T.O.V.A. test. The T.O.V.A. provides healthcare professionals with objective measurements of attention and inhibitory control. The visual T.O.V.A. aids in the assessment of, and evaluation of treatment for, attention deficits, including attention-deficit/hyperactivity disorder (ADHD). The auditory T.O.V.A. aids in the assessment of attention deficits, including ADHD. T.O.V.A. results should only be interpreted by qualified professionals.
TOVA COMPANY, THE
USB Device
In Commercial Distribution

  • 00862290000302 ()


  • Cognitive assessment software

Welch Allyn, Inc. - 00732094225938

Welch Allyn Handheld RetinaVue 100 Imager with Charging Dock, Reusable Eye Cup, USB Cable, and 1 Year Partners in Care Comprehensive Program; Lithium-Ion 3.6V Battery. Note: Diagnostic interpretation services are a necessary component of the RetinaVue solution and are contracted directly with RetinaVue P.C.
WELCH ALLYN, INC.
901103
In Commercial Distribution

  • 00732094225938 ()
RV100-B

  • Ophthalmic fundus camera

Welch Allyn, Inc. - 00732094223873

Topcon TRC-NW400 Non-Mydriatic Retinal Desktop Camera, use with RetinaVue Network. Note: Diagnostic interpretation services are a necessary component of the RetinaVue solution and are contracted directly with RetinaVue P.C.
WELCH ALLYN, INC.
901103
Not in Commercial Distribution

  • 00732094223873 ()
723427

  • Ophthalmic fundus camera

Welch Allyn, Inc. - 00732094214758

RETeval-DR Disp. Sensor Strips 50-Pair
WELCH ALLYN, INC.
901102
In Commercial Distribution

  • 00732094214758 ()
RETEVAL-SS-50

  • Ophthalmic fundus camera

Welch Allyn, Inc. - 00732094214741

Welch Allyn RETeval-DR Electroretinograph including Disposable Sensor Strips (2 Packs of 50 ea), Charging Dock, and USB Cable; Lithium-Ion Battery (#RETeval-ACC-02); 100-240 V, 50-60 Hz, IEC Plug Types A, G, E/F, and I; Multiple Languages
WELCH ALLYN, INC.
901101
In Commercial Distribution

  • 00732094214741 ()
RETEVAL-001

  • Ophthalmic fundus camera

Welch Allyn, Inc. - 00732094258851

RETINAVUE700 IMAGER SET US PLUG
WELCH ALLYN, INC.
901124
Not in Commercial Distribution

  • 00732094258851 ()
RV700-B

  • Ophthalmic fundus camera

Welch Allyn, Inc. - 00732094252835

RETINAVUE100 IMAGER PRO SET US PLUG
WELCH ALLYN, INC.
901103
In Commercial Distribution

  • 00732094252835 ()
RV100PRO-B

  • Ophthalmic fundus camera

Welch Allyn, Inc. - 00732094299939

RETINAVUE700 IMAGER US
WELCH ALLYN, INC.
901124
Not in Commercial Distribution

  • 00732094299939 ()
  • 00732094323214 ()
RV700 B

  • Ophthalmic fundus camera

Welch Allyn, Inc. - 00732094336832

TRIAL RETINAVUE700 IMAGER SET US PLUG
WELCH ALLYN, INC.
901124
In Commercial Distribution

  • 00732094336832 ()
RV700-BT

  • Ophthalmic fundus camera

Welch Allyn, Inc. - 00732094323948

RV700 IMAGER SET TRADE-UP DISTRIBUTOR
WELCH ALLYN, INC.
901124
Not in Commercial Distribution

  • 00732094323948 ()
RV700TUD-B

  • Ophthalmic fundus camera

Brain Gauge MD - 00860000709408

The Brain Gauge MD is a computerized cognitive assessment aid that assesses cognitive function based on the perception of simple taps and vibrations delivered to the fingertips of the patient's hand.
CORTICAL METRICS, LLC
1.0
In Commercial Distribution

  • 00860000709408 ()

  • Depth: 73 Millimeter
  • Width: 113 Millimeter
  • Height: 40 Millimeter


  • Cognitive assessment software

Cognivue Thrive - 00860000564052

No Description
COGNIVUE, INC.
Portable Device Model 2
In Commercial Distribution

  • 00860000564052 ()


  • Cognitive assessment software

Cognivue Clarity - 00860000564045

No Description
COGNIVUE, INC.
Portable Device Model 2
In Commercial Distribution

  • 00860000564045 ()


  • Cognitive assessment software

Cognivue Thrive - 00860000564038

No Description
COGNIVUE, INC.
Portable Device
In Commercial Distribution

  • 00860000564038 ()


  • Cognitive assessment software

Cognivue Clarity - 00860000564021

No Description
COGNIVUE, INC.
Portable Device
In Commercial Distribution

  • 00860000564021 ()


  • Cognitive assessment software

Cognivue Advanced Desktop - 00860000564014

No Description
COGNIVUE, INC.
Desktop Unit
In Commercial Distribution

  • 00860000564014 ()


  • Cognitive assessment software

Cognivue Advanced with Cart - 00860000564007

No Description
COGNIVUE, INC.
Cart Unit
In Commercial Distribution

  • 00860000564007 ()


  • Cognitive assessment software

Verily Numetric Retinal Camera - 00860000249584

Verily Numetric Retinal Camera is a non-contact, high resolution digital imaging device which is suitable for photographing, displaying and storing images of the retina segment of the eye to be evaluated under non-mydriatic conditions. Verily Numetric Retinal Camera is indicated for in-vivo viewing of the posterior segment of the eye. The images are intended for use as an aid to clinicians in the evaluation, diagnosis, and documentation of ocular health.
VERILY LIFE SCIENCES LLC
VNRC -101
In Commercial Distribution

  • 00860000249584 ()


  • Ophthalmic fundus camera

Vivicon - 00858848006445

Ophthalmic Camera
OPTOVUE, INC.
Vivicon
In Commercial Distribution

  • 00858848006445 ()
700-53597-001

  • Ophthalmic fundus camera

iCam - 00858848006414

iCam Camera Head 5MP
OPTOVUE, INC.
iCam100
In Commercial Distribution

  • 00858848006414 ()
700-49517-004

  • Ophthalmic fundus camera

iCam - 00858848006339

iCam Camera Head 5 MP
OPTOVUE, INC.
iCam100
In Commercial Distribution

  • 00858848006339 ()
700-49517-003

  • Ophthalmic fundus camera

iCam - 00858848006322

iCam Camera Head 5 MP
OPTOVUE, INC.
iCam100
In Commercial Distribution

  • 00858848006322 ()
700-49517-002

  • Ophthalmic fundus camera

iCam - 00858848006278

iCam Camera Head 5 MP
OPTOVUE, INC.
iCam100
In Commercial Distribution

  • 00858848006278 ()
700-49517-001

  • Ophthalmic fundus camera

iCam - 00858848006780

iCam 12 MP
OPTOVUE, INC.
iCam100
In Commercial Distribution

  • 00858848006780 ()
700-54524-001

  • Ophthalmic fundus camera

Phoenix ICON GO - 00857253006088

The Phoenix ICON GO is a portable, hand held, ophthalmic imaging device intended for general opthalmic imaging of the retina, cornea, and external structures of the eye.
Phoenix Clinical
PCI 40-2001
In Commercial Distribution

  • 00857253006088 ()


  • Ophthalmic fundus camera

Phoenix ICON Cart System - 00857253006057

The Phoenix ICON retinal imaging system is a wide-field, handheld, high resolution, real time retinal imaging device. It is intended to be used for general ophthalmic imaging including retinal, corneal, and external structures of the eye.
Phoenix Clinical
PCI 40-1000
In Commercial Distribution

  • 00857253006057 ()


  • Ophthalmic fundus camera

Phoenix Clinical ICON - 00857253006040

The ICON is a wide-field high-resolution retinal imaging system optimized for pediatric patients to age 18. The image is captured using a hand-held corneal contact camera and is displayed in real-time. The camera contacts the cornea to image the retina and is connected to a cart with the power supplies, controls, computer and display unit. The light source for bright field imaging is a white-light LED located in the hand piece and the hand piece is connected to a mobile through a USB cable and cables for focus motor and LED light. Software in the computer performs library functions and can capture either still or video data. Data can be exported with or without patient information.
Phoenix Clinical
PJZ
In Commercial Distribution

  • 00857253006040 ()
PCI-40-1000-P

  • Ophthalmic fundus camera

Phoenix Clinical ICON Control Box - 00857253006026

Phoenix Clinical ICON Control Box
Phoenix Clinical
PCI 40-1003
In Commercial Distribution

  • 00857253006026 ()
PCI 40-1003

  • Ophthalmic fundus camera

Phoenix Clinical ICON Cart - 00857253006002

Phoenix Clinical ICON cart assembly.
Phoenix Clinical
PCI 40-1001
In Commercial Distribution

  • 00857253006002 ()
PCI 40-1001

  • Ophthalmic fundus camera

Phoenix Clinical White Light Module - 00857253006064

White light module for the Phoenix Clinical ICON retinal imaging system.
Phoenix Clinical
PCI 40-1005
In Commercial Distribution

  • 00857253006064 ()
  • 00857253006095 ()
  • 00857253006125 ()
PCI 40-1005

  • Ophthalmic fundus camera

identifeye Camera System, reconditioned - 00850067214281

The identifeye Camera System is a fundus ophthalmic camera reconditioned.
Identifeye Health Inc.
850-30004-00
In Commercial Distribution

  • 00850067214281 ()


  • Ophthalmic fundus camera

identifeye Camera System - 00850067214274

The identifeye Camera System is a fundus ophthalmic camera.
Identifeye Health Inc.
850-30003-00
In Commercial Distribution

  • 00850067214274 ()


  • Ophthalmic fundus camera

identifeye Camera System, power supply - 00850067214236

identifeye Camera System power supply accessory
Identifeye Health Inc.
815-30020-00
In Commercial Distribution

  • 00850067214236 ()


  • Ophthalmic fundus camera

identifeye Camera System, tablet - 00850067214229

identifeye Camera System tablet accessory
Identifeye Health Inc.
815-30023-01
In Commercial Distribution

  • 00850067214229 ()


  • Ophthalmic fundus camera

Paxos Scope - 00851434007024

DigiSight Technologies Inc. Paxos Scope Ophthalmic Camera
DIGISIGHT TECHNOLOGIES, INC.
41177
In Commercial Distribution

  • 00851434007024 ()


  • Ophthalmic fundus camera

Paxos Scope - 00851434007017

DigiSIght Technologies Inc. Paxos Scope Ophthalmic Camera with optional 20D acrylic lens
DIGISIGHT TECHNOLOGIES, INC.
40807
In Commercial Distribution

  • 00851434007017 ()


  • Ophthalmic fundus camera
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