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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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mo-Vis - 05407008320379

Twister Bended Tube (300 mm) Green
mo-Vis
P005-64
In Commercial Distribution

  • 05407008320379 ()


  • Assistive input-control operation training device, selection techniques

mo-Vis - 05407008320362

Twister Bended Tube (300 mm) Blue
mo-Vis
P005-63
In Commercial Distribution

  • 05407008320362 ()


  • Assistive input-control operation training device, selection techniques

mo-Vis - 05407008320355

Twister Bended Tube (300 mm) Yellow
mo-Vis
P005-62
In Commercial Distribution

  • 05407008320355 ()


  • Assistive input-control operation training device, selection techniques

mo-Vis - 05407008320348

Twister Bended Tube (300 mm) Red
mo-Vis
P005-61
In Commercial Distribution

  • 05407008320348 ()


  • Assistive input-control operation training device, selection techniques

mo-Vis - 05407008320331

Twister Bended Tube (300 mm) Black
mo-Vis
P005-60
In Commercial Distribution

  • 05407008320331 ()


  • Assistive input-control operation training device, selection techniques

mo-Vis - 05407008320324

Twister Bended Tube (1500 mm) Green
mo-Vis
P005-54
In Commercial Distribution

  • 05407008320324 ()


  • Assistive input-control operation training device, selection techniques

mo-Vis - 05407008320317

Twister Bended Tube (1500 mm) Blue
mo-Vis
P005-53
In Commercial Distribution

  • 05407008320317 ()


  • Assistive input-control operation training device, selection techniques

mo-Vis - 05407008320300

Twister Bended Tube (1500 mm) Yellow
mo-Vis
P005-52
In Commercial Distribution

  • 05407008320300 ()


  • Assistive input-control operation training device, selection techniques

mo-Vis - 05407008320294

Twister Bended Tube (1500 mm) Red
mo-Vis
P005-51
In Commercial Distribution

  • 05407008320294 ()


  • Assistive input-control operation training device, selection techniques

mo-Vis - 05407008320287

Twister Bended Tube (1500 mm) Black
mo-Vis
P005-50
In Commercial Distribution

  • 05407008320287 ()


  • Assistive input-control operation training device, selection techniques

mo-Vis - 05407008320270

Twister Button (300 mm) Green
mo-Vis
P005-89
In Commercial Distribution

  • 05407008320270 ()


  • Assistive input-control operation training device, selection techniques

mo-Vis - 05407008320263

Twister Button (300 mm) Blue
mo-Vis
P005-88
In Commercial Distribution

  • 05407008320263 ()


  • Assistive input-control operation training device, selection techniques

mo-Vis - 05407008320256

Twister Button (300 mm) Yellow
mo-Vis
P005-87
In Commercial Distribution

  • 05407008320256 ()


  • Assistive input-control operation training device, selection techniques

mo-Vis - 05407008320249

Twister Button (300 mm) Red
mo-Vis
P005-86
In Commercial Distribution

  • 05407008320249 ()


  • Assistive input-control operation training device, selection techniques

mo-Vis - 05407008320232

Twister Button (300 mm) Black
mo-Vis
P005-85
In Commercial Distribution

  • 05407008320232 ()


  • Assistive input-control operation training device, selection techniques

mo-Vis - 05407008320225

Twister Button (1500 mm) Green
mo-Vis
P005-79
In Commercial Distribution

  • 05407008320225 ()


  • Assistive input-control operation training device, selection techniques

mo-Vis - 05407008320218

Twister Button (1500 mm) Blue
mo-Vis
P005-78
In Commercial Distribution

  • 05407008320218 ()


  • Assistive input-control operation training device, selection techniques

mo-Vis - 05407008320201

Twister Button (1500 mm) Yellow
mo-Vis
P005-77
In Commercial Distribution

  • 05407008320201 ()


  • Assistive input-control operation training device, selection techniques

mo-Vis - 05407008320195

Twister Button (1500 mm) Red
mo-Vis
P005-76
In Commercial Distribution

  • 05407008320195 ()


  • Assistive input-control operation training device, selection techniques

mo-Vis - 05407008320188

Twister Button (1500 mm) Black
mo-Vis
P005-75
In Commercial Distribution

  • 05407008320188 ()


  • Assistive input-control operation training device, selection techniques

mo-Vis - 05407008320164

Actuator Keypad Paddle R-net CJSM2
mo-Vis
P016-99
In Commercial Distribution

  • 05407008320164 ()


  • Assistive input-control operation training device, selection techniques

mo-Vis - 05407008320157

Actuator Keypad Button R-net CJSM2
mo-Vis
P016-98
In Commercial Distribution

  • 05407008320157 ()


  • Assistive input-control operation training device, selection techniques

mo-Vis - 05407008320140

Actuator Keypad Paddle R-net CJSM1
mo-Vis
P016-97
In Commercial Distribution

  • 05407008320140 ()


  • Assistive input-control operation training device, selection techniques

mo-Vis - 05407008320133

Actuator Keypad Button R-net CJSM1
mo-Vis
P016-96
In Commercial Distribution

  • 05407008320133 ()


  • Assistive input-control operation training device, selection techniques

TWISTER - 00606509900140

A device designed to assist a person with a disability in the techniques of selecting the correct input device in order to operate a connected primary device.
Pride Mobility Products Corp
TWISTER
In Commercial Distribution

  • 00606509900140 ()
N/A

  • Assistive input-control operation training device, selection techniques

Bio30+ System Physio Accel - 05056336800192

Ion exchange chromatography analyzer with lithium accelerated column, LED monitor, computer, autosampler and Openlab software
BIOCHROM LIMITED
80-6000-50
In Commercial Distribution

  • 05056336800192 ()


  • Amino acid analyser IVD

Remote Network Station - 00851725007269

No Audio Remote Network Station with Dell OptiPlex 7490 23.8" All-In-One Computer SW 02-18 unicast
Nihon Kohden Digital Health Solutions, LLC
RNS-6804-7490-U
In Commercial Distribution

  • 00851725007269 ()
RNS-6804-7490-U

  • Centralized patient monitor

Remote Network Station - 00851725007245

No Audio Remote Network Station with Dell OptiPlex 7480 23.8" All-In-One Computer SW 02-18 unicast
Nihon Kohden Digital Health Solutions, LLC
RNS-6804-7480-U
In Commercial Distribution

  • 00851725007245 ()
RNS-6804-7480-U

  • Centralized patient monitor

Insight Discovery Algometer - 00890477000159

No Description
SRS Medical Systems, Inc.
900-015-2
In Commercial Distribution

  • 00890477000159 ()


  • Biofeedback system application software
  • Electromyograph

Insight Discovery Thermal - 00890477000074

No Description
SRS Medical Systems, Inc.
900-034
In Commercial Distribution

  • 00890477000074 ()


  • Biofeedback system application software
  • Electromyograph

Insight Discovery Thermal (w/cable) - 00890477000296

No Description
SRS Medical Systems, Inc.
900-014-2
In Commercial Distribution

  • 00890477000296 ()


  • Biofeedback system application software
  • Electromyograph

Insight Discovery PWP (w/cable) - 00890477000173

No Description
SRS Medical Systems, Inc.
900-023
In Commercial Distribution

  • 00890477000173 ()


  • Biofeedback system application software
  • Electromyograph

Insight Discovery PWP - 00890477000081

No Description
SRS Medical Systems, Inc.
900-036
In Commercial Distribution

  • 00890477000081 ()


  • Biofeedback system application software
  • Electromyograph

Cardea SOLO - 00857553006139

Cardea SOLO PC Software - ECG analysis software (D300)
CARDIAC INSIGHT, INC.
D300
In Commercial Distribution

  • 00857553006139 ()
D300

  • Electrocardiographic ambulatory recorder

Stealth System S300 - 00857553006092

StealthView Software & Smart Cable - ECG analysis software (D300) and data transfer cable (C300).
CARDIAC INSIGHT, INC.
C300/D300
Not in Commercial Distribution

  • 00857553006092 ()
  • 00857553006061 ()
C300/D300

  • Electrocardiographic ambulatory recorder

WorkMate Claris™ - 05415067013132

Cart 48 Inch
ST. JUDE MEDICAL, INC.
H701313
In Commercial Distribution

  • 05415067013132 ()
H701313

  • Cardiac catheterization monitoring system

WorkMate Claris™ - 05415067013125

Cart 24 Inch
ST. JUDE MEDICAL, INC.
H701312
In Commercial Distribution

  • 05415067013125 ()
H701312

  • Cardiac catheterization monitoring system

VidiStar PACS & DICOM Viewer Software - 00869047000431

The VidiStar PACS & DICOM Viewer Software system is a picture archiving and communications system (PACS) intended to be used as a networked Digital Imaging and Communications in Medicine (DICOM) and non-DICOM information and data management system. The VidiStar PACS & DICOM Viewer Software is comprised of modular software programs that run on standard “off-the-shelf” personal computers, business computers, and servers running standard operating systems. VidiStar PACS & DICOM Viewer Software system is an image, data storage and display software that accepts DICOM data from laboratories, which support DICOM standard imaging data and structured reporting transfer(s). The system provides the capability to: organize images generated by OEM vendor equipment, perform digital manipulation, create graphical representations of anatomical areas, perform quantitative measurements, and create DICOM structure reports, all over the Internet.
Fujifilm Healthcare Americas Corporation
4.X.X
In Commercial Distribution

  • 00869047000431 ()


  • Radiological PACS software

VIGILEO - 00690103187267

VIGILEO ANALOG SLAVE CABLE, DATEX DIN7
Edwards Lifesciences LLC
MHFD1
In Commercial Distribution

  • 00690103187267 ()

  • Length: 96 Inch
MHFD1

  • Electrical-only medical device connection cable, reusable

VIGILEO - 00690103186093

PRESSURE SLAVE CABLE
Edwards Lifesciences LLC
MHANM8
In Commercial Distribution

  • 00690103186093 ()

  • Length: 8 Feet
MHANM8

  • Electrical-only medical device connection cable, reusable
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