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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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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 Thrive - 00860000564038

No Description
COGNIVUE, INC.
Portable Device
In Commercial Distribution

  • 00860000564038 ()


  • Cognitive assessment software

Cognivue Advanced Desktop - 00860000564014

No Description
COGNIVUE, INC.
Desktop Unit
In Commercial Distribution

  • 00860000564014 ()


  • Cognitive assessment software

1 BY ONE - 00858069007184

No Description
1BYONEPRODUCTS INC.
9-JK14US05
In Commercial Distribution

  • 00858069007191 ()
  • 00858069007184 ()
  • 10858069007198 ()


  • Telemetric sphygmomanometer

1 BY ONE - 00858069007153

No Description
1BYONEPRODUCTS INC.
9-JK14US06
In Commercial Distribution

  • 00858069007177 ()
  • 00858069007153 ()
  • 10858069007174 ()


  • Telemetric sphygmomanometer

1BYONE - 00858069007030

Wireless Arm Blood Pressure Monitor
1BYONEPRODUCTS INC.
TMB-1585-BT
In Commercial Distribution

  • 10858069007044 ()
  • 00858069007047 ()
  • 00858069007030 ()


  • Telemetric sphygmomanometer

iCam - 00858848006780

iCam 12 MP
OPTOVUE, INC.
iCam100
In Commercial Distribution

  • 00858848006780 ()
700-54524-001

  • 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

Captus 4000e Thyroid Uptake System with 2 in well - 00859942006423

The Captus 4000e is a PC based Thyroid Uptake System, on a ergonomically designed mobile stand. It includes a 1024 channel MCA, automated Quality Assurance, Thyroid Uptake Module, and Bioassay module. This model includes a well counter with 2 inch of lead shielding.
Mirion Technologies (capintec), Inc.
5430-30154
In Commercial Distribution

  • 00859942006423 ()
5430-30154

  • Thyroid-uptake nuclear medicine system

Captus 4000e Thyroid Uptake System with Well - 00859942006102

The Captus 4000e is a PC based Thyroid Uptake System, on a ergonomically designed mobile stand. It includes a 1024 channel MCA, automated Quality Assurance, Thyroid Uptake Module, Bioassay module, Wipe Test Module, and Lab Tests.
Mirion Technologies (capintec), Inc.
Captus 4000e Thyroid System with Well
In Commercial Distribution

  • 00859942006102 ()
5430-30152

  • Thyroid-uptake nuclear medicine system

Captus 4000e Thyroid Uptake System - 00859942006096

The Captus 4000e is a PC based Thyroid Uptake System, on a ergonomically designed mobile stand. It includes a 1024 channel MCA, automated Quality Assurance, Thyroid Uptake Module, and Bioassay module.
Mirion Technologies (capintec), Inc.
Captus 4000e Thyroid Uptake System
In Commercial Distribution

  • 00859942006096 ()
5430-30151

  • Thyroid-uptake nuclear medicine system

Cognivue Clarity - 00860000564045

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

  • 00860000564045 ()


  • Cognitive assessment software

Cognivue Clarity - 00860000564021

No Description
COGNIVUE, INC.
Portable Device
In Commercial Distribution

  • 00860000564021 ()


  • 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

INTELLISPACE™ COGNITION - 00884838104587

Philips IntelliSpace Cognition (ISC) is a digital assessment platform that supports Healthcare Professionals in assessing the cognition of individuals. It is a cloud-based Software as a Service consisting of both a patient interface on a tablet and a clinician interface that can be used on any PC or tablet. The patient uses a digital pencil on the tablet to complete a cognitive assessment. The application immediately scores the tests, compares to norms and displays the results in terms of cognitive domains as part of a comprehensive report.
Philips Electronics Nederland B.V.
5.0.x.x
Not in Commercial Distribution

  • 00884838104587 ()
821401000000

  • Cognitive assessment software

INTELLISPACE™ COGNITION - 00884838103900

Philips IntelliSpace Cognition (ISC) is a digital assessment platform that supports Healthcare Professionals in assessing the cognition of individuals. It is a cloud-based Software as a Service consisting of both a patient interface on a tablet and a clinician interface that can be used on any PC or tablet. The patient uses a digital pencil on the tablet to complete a cognitive assessment. The application immediately scores the tests, compares to norms and displays the results in terms of cognitive domains as part of a comprehensive report.
Philips Electronics Nederland B.V.
4.0.x.x
Not in Commercial Distribution

  • 00884838103900 ()
821401000000

  • Cognitive assessment software

INTELLISPACE™ COGNITION - 00884838103535

Philips IntelliSpace Cognition (ISC) is a digital assessment platform that supports Healthcare Professionals in assessing the cognition of individuals. It is a cloud-based Software as a Service consisting of both a patient interface on a tablet and a clinician interface that can be used on any PC or tablet. The patient uses a digital pencil on the tablet to complete a cognitive assessment. The application immediately scores the tests, compares to norms and displays the results in terms of cognitive domains as part of a comprehensive report.
Philips Electronics Nederland B.V.
3.0.x.x
Not in Commercial Distribution

  • 00884838103535 ()
821401000000

  • Cognitive assessment software

INTELLISPACE™ COGNITION - 00884838101036

Philips IntelliSpace Cognition (ISC) is a digital assessment platform that supports Healthcare Professionals in assessing the cognition of individuals. It is a cloud-based Software as a Service consisting of both a patient interface on a tablet and a clinician interface that can be used on any PC or tablet. The patient uses a digital pencil on the tablet to complete a cognitive assessment. The application immediately scores the tests, compares to norms and displays the results in terms of cognitive domains as part of a comprehensive report.
Philips Electronics Nederland B.V.
2.0.x.x
Not in Commercial Distribution

  • 00884838101036 ()


  • Cognitive assessment software

INTELLISPACE™ COGNITION - 00884838098244

No Description
Philips Electronics Nederland B.V.
1.1.X
Not in Commercial Distribution

  • 00884838098244 ()
821401000000

  • Cognitive assessment software

ImPACT Version 4 - 00864127000349

ImPACT is intended for use as a computer-based neurocognitive test battery to aid in the assessment and management of concussion. ImPACT is a neurocognitive test battery that provides healthcare professionals with objective measure of neurocognitive functioning as an assessment aid and in the management of concussion in individuals ages 12-80.
IMPACT APPLICATIONS, INC.
4
In Commercial Distribution

  • 00864127000349 ()


  • Cognitive assessment software

ImPACT Quick Test - 00864127000325

ImPACT Quick Test is intended for use as a computerized cognitive test to aid in the assessment of concussion in individuals ages 12-70
IMPACT APPLICATIONS, INC.
1
Not in Commercial Distribution

  • 00864127000325 ()


  • Cognitive assessment software

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

RetCam Portable - 00864222000428

The RetCam Portable Ophthalmic Imaging System is designed to allow the quick and easy capture of wide field, high resolution, fully digital images and videos of the eye.
NATUS MEDICAL INC
RetCam Portable
In Commercial Distribution



  • Ophthalmic fundus camera

RetCam Shuttle - 00864222000411

The RetCam Shuttle Ophthalmic Imaging System is designed to allow the quick and easy capture of wide field, high resolution, fully digital images and videos of the eye.
NATUS MEDICAL INC
RetCam Shuttle
In Commercial Distribution



  • Ophthalmic fundus camera

RetCam 3 - 00864222000404

RetCam 3 Ophthalmic Imaging System is designed to allow the quick and easy capture of wide field, high resolution, fully digital images and videos of the eye.
NATUS MEDICAL INC
RetCam 3
In Commercial Distribution



  • Ophthalmic fundus camera

ImPACT Quick Test - 00864127000356

ImPACT Quick Test is intended for use as a computerized cognitive test to aid in the assessment of concussion in individuals ages 12-70
IMPACT APPLICATIONS, INC.
2
In Commercial Distribution

  • 00864127000356 ()


  • Cognitive assessment software

Cognitive Impairment Screener - 00864127000332

No Description
IMPACT APPLICATIONS, INC.
1
In Commercial Distribution

  • 00864127000332 ()


  • Cognitive assessment software

1BYONE - 00863696000309

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

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


  • Telemetric sphygmomanometer

IRRAflow Laser Leveler Package - 00868643000463

No Description
Irras USA, Inc.
ICLS 010
In Commercial Distribution

  • 10868643000460 ()
  • 00868643000463 ()
  • 20868643000467 ()
ICLS 010

  • Patient monitoring system module, intracranial pressure

EntireEye Portable - 00860011978305

No Description
RETIVUE, LLC
WFP-B-G1.5-0A
In Commercial Distribution

  • 00860011978305 ()


  • Ophthalmic fundus camera

SPARK Neuro - 00860011882022

No Description
Spark Neuro Inc.
SP010000
In Commercial Distribution

  • 00860011882022 ()


  • Cognitive assessment software
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