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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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Axiom - 00840363368689

3 x 4 Lateral Pads, Curved with S/A Mounting Hardware for BTX Left
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368689 ()

  • Width: 4 Inch
  • Length: 3 Inch
PBLSC3x4BL

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363368672

4 x 5 Lateral Pads, Flat with S/A Mounting Hardware for BTX Left
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368672 ()

  • Length: 4 Inch
  • Width: 5 Inch
PBLS4x5BL

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363368665

3 x 4 Lateral Pads, Flat with S/A Mounting Hardware for BTX Left
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368665 ()

  • Width: 4 Inch
  • Length: 3 Inch
PBLS3x4BL

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363368658

4 x 5 Lateral Pads, Flat with Fixed Modular Mounting Hardware for BTX Left
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368658 ()

  • Width: 5 Inch
  • Length: 4 Inch
PBLFM4x5BL

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363368641

3 x 4 Lateral Pads, Flat with Fixed Modular Mounting Hardware for BTX Left
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368641 ()

  • Width: 4 Inch
  • Length: 3 Inch
PBLFM3x4BL

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363367637

4 x 5 Lateral Pelvic Pads with Swing Away Mounting Hardware (Right) (E0956,E1028)
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363367637 ()

  • Width: 5 Inch
  • Length: 4 Inch
PLASP4x5PR

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363367620

3 x 4 Lateral Pelvic Pads with Swing Away Mounting Hardware (Right) (E0956,E1028)
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363367620 ()

  • Width: 4 Inch
  • Length: 3 Inch
PLASP3x4PR

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363367590

4 x 5 Lateral Pelvic Pads with Swing Away Mounting Hardware (Left) (E0956,E1028)
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363367590 ()

  • Length: 4 Inch
  • Width: 5 Inch
PLASP4x5PL

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363367583

3 x 4 Lateral Pelvic Pads with Swing Away Mounting Hardware (Left) (E0956,E1028)
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363367583 ()

  • Length: 3 Inch
  • Width: 4 Inch
PLASP3x4PL

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363367552

4 x 5 Lateral Pelvic Pads with Swing Away Mounting Hardware (Pair) (E0956,E1028)
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363367552 ()

  • Length: 4 Inch
  • Width: 5 Inch
PLASP4x5PP

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363367545

3 x 4 Lateral Pelvic Pads with Swing Away Mounting Hardware (Pair) (E0956,E1028)
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363367545 ()

  • Length: 3 Inch
  • Width: 4 Inch
PLASP3x4PP

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363368986

3 x 4 Lateral Pads, Curved with S/A Mounting Hardware for BTX Right
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368986 ()

  • Length: 3 Inch
  • Width: 4 Inch
PLLSC3x4BR

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363368962

3 x 4 Lateral Pads, Flat with S/A Mounting Hardware for BTX Right
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368962 ()

  • Length: 3 Inch
  • Width: 4 Inch
PLLS3x4BR

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363368948

3 x 4 Lateral Pads, Flat with Fixed Modular Mounting Hardware for BTX Right
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368948 ()

  • Width: 4 Inch
  • Length: 3 Inch
PLLFM3x4BR

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363368894

4 x 5 Lateral Pads, Curved with S/A Mounting Hardware for BTX Left
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368894 ()

  • Width: 5 Inch
  • Length: 4 Inch
PLLSC4x5BL

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363368870

4 x 5 Lateral Pads, Flat with S/A Mounting Hardware for BTX Left
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368870 ()

  • Width: 5 Inch
  • Length: 4 Inch
PLLS4x5BL

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363368863

3 x 4 Lateral Pads, Flat with S/A Mounting Hardware for BTX Left
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368863 ()

  • Width: 4 Inch
  • Length: 3 Inch
PLLS3x4BL

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363368849

3 x 4 Lateral Pads, Flat with Fixed Modular Mounting Hardware for BTX Left
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368849 ()

  • Length: 3 Inch
  • Width: 4 Inch
PLLFM3x4BL

  • Wheelchair head/trunk support, prefabricated

AincA® - B005001950

Manometer, Wall Mount Dovetail, Removable Vertical Mount w/Hardware, fits all 00-199, 00-274 Gauges
ANESTHESIA ASSOCIATES, INC.
00-195
In Commercial Distribution

  • B005001950 ()
00-195

  • Airway pressure monitor, non-powered

Axon - 09413000107500

Axon Neurofeedback software Application for iOS
EXSURGO LIMITED
iOS
In Commercial Distribution

  • 09413000107500 ()
100318

  • Psychophysiological biofeedback system

Axon 2 - 09413000095982

EEG-based Neurofeedback Headset for use with the Axon mobile App, enabling users to modulate and redirect brain activity towards frequencies associated with relaxation and calm focused attention.
EXSURGO LIMITED
100500
In Commercial Distribution

  • 09413000095982 ()
100500

  • Psychophysiological biofeedback system

Axon - 09413000078510

Neurofeedback Software Application for Android
EXSURGO LIMITED
Android
In Commercial Distribution

  • 09413000078510 ()
100321

  • Psychophysiological biofeedback system

Axon - 09413000078459

EEG Biofeedback (Neurofeedback) Kit - Large includes Axon EEG headset - Large, Tablet with Axon Neurofeedback Software Application
EXSURGO LIMITED
Large
Not in Commercial Distribution

  • 09413000078459 ()
100161

  • Psychophysiological biofeedback system

Axon - 09413000078442

Neurofeedback Kit - Medium includes Axon EEG headset - Medium, Tablet with Axon Neurofeedback Software Application
EXSURGO LIMITED
Medium
Not in Commercial Distribution

  • 09413000078442 ()
100160

  • Psychophysiological biofeedback system

Axon - 09413000078435

Neurofeedback Kit - Small includes Axon EEG headset - Small, Tablet with Axon Neurofeedback Software Application
EXSURGO LIMITED
Small
Not in Commercial Distribution

  • 09413000078435 ()
100140

  • Psychophysiological biofeedback system

Axon - 09413000078428

EEG Headset - Large
EXSURGO LIMITED
Large
Not in Commercial Distribution

  • 09413000078428 ()
100143

  • Psychophysiological biofeedback system

Axon - 09413000078411

EEG Headset - Small
EXSURGO LIMITED
Small
Not in Commercial Distribution

  • 09413000078411 ()
100141

  • Psychophysiological biofeedback system

Axon - 09413000077094

EEG Headset - Medium
EXSURGO LIMITED
Medium
Not in Commercial Distribution

  • 09413000077094 ()
100142

  • Psychophysiological biofeedback system

Neuroband - 00850010086026

Neuroband is a wireless sleep monitoring system consisting of a wearable headband that contains sensors to monitor sleep, and a mobile application. Neuroband is intended to generate reports to provide information about sleep, in-home, or clinical trial settings.
DREEM
GFM30MD
Not in Commercial Distribution

  • 00850010086026 ()


  • Psychophysiological biofeedback system

Neuroband - 00850010086033

Neuroband is a wireless sleep monitoring system consisting of a wearable headband that contains sensors to monitor sleep, and a mobile application. Neuroband is intended to generate reports to provide information about sleep, in-home, or clinical trial settings.
DREEM
GFM30SB
Not in Commercial Distribution

  • 00850010086033 ()


  • Psychophysiological biofeedback system

Dreem 2 - 00850010086019

Dreem 2 is a wireless sleep monitoring system consisting of a wearable headband that contains sensors to monitor sleep and a mobile application. Dreem 2 is intended to aid in relaxing and falling asleep and to generate reports, advices and contents to help the user better understand his or her sleep, and take steps to improve it.
DREEM
EFM00MD
Not in Commercial Distribution

  • 00850010086019 ()


  • Psychophysiological biofeedback system

Protective Cover - 04547410483437

Protective cover is placed on a flat panel sensor (DR-ID 1836SE) during recumbent exposure and is covered to reinforce the strength.
FUJIFILM CORPORATION
DR1836 SE PROTECTIVE COVER E
In Commercial Distribution

  • 04547410483437 ()

  • 470x860x25mm


  • Stationary basic diagnostic x-ray system, digital

D-EVOIII G80i - 04547410483420

The DR-ID 1836SE incorporate a GOS indirect panel. The indirect-conversion flat panel sensor is a device which acquires a general radiograph.
FUJIFILM CORPORATION
DR-ID 1836 SE E
In Commercial Distribution

  • 04547410483420 ()

  • 460x850x15mm


  • Stationary basic diagnostic x-ray system, digital

D-EVOIII G43i - 04547410480788

The DR-ID 1831SE and DR-ID 1832SE incorporate a GOS indirect panel. The indirect-conversion flat panel sensor is a device which acquires a general radiograph.
FUJIFILM CORPORATION
DR-ID 1832 SE NON CE E
In Commercial Distribution

  • 04547410480788 ()

  • 460x460x15mm


  • Stationary basic diagnostic x-ray system, digital

D-EVOIII G35i - 04547410480771

The DR-ID 1831SE and DR-ID 1832SE incorporate a GOS indirect panel. The indirect-conversion flat panel sensor is a device which acquires a general radiograph.
FUJIFILM CORPORATION
DR-ID 1831 SE NON CE E
In Commercial Distribution

  • 04547410480771 ()

  • 460x384x15mm


  • Stationary basic diagnostic x-ray system, digital

D-EVOIII C25i - 04547410478655

The DR-ID 1811SE, DR-ID 1812SE and DR-ID 1814SE incorporate a CsI indirect panel. The indirect-conversion flat panel sensor is a device which acquires a general radiograph.
FUJIFILM CORPORATION
DR-ID 1814 SE NON CE E
In Commercial Distribution

  • 04547410478655 ()

  • 333x282x15mm


  • Stationary basic diagnostic x-ray system, digital

D-EVOIII C43i - 04547410478648

The DR-ID 1811SE, DR-ID 1812SE and DR-ID 1814SE incorporate a CsI indirect panel. The indirect-conversion flat panel sensor is a device which acquires a general radiograph.
FUJIFILM CORPORATION
DR-ID 1812 SE NON CE E
In Commercial Distribution

  • 04547410478648 ()

  • 460x460x15mm


  • Stationary basic diagnostic x-ray system, digital

D-EVOIII C35i - 04547410478631

The DR-ID 1811SE, DR-ID 1812SE and DR-ID 1814SE incorporate a CsI indirect panel. The indirect-conversion flat panel sensor is a device which acquires a general radiograph.
FUJIFILM CORPORATION
DR-ID 1811 SE NON CE E
In Commercial Distribution

  • 04547410478631 ()

  • 460x384x15mm


  • Stationary basic diagnostic x-ray system, digital

FDR D-EVO Mobile Compo - 04547410457704

DR-ID 800 (FDR D-EVO Mobile Compo) is digital radiography equipment for mounting on the Mobile Cart and employs an indirect-conversion FPD.
FUJIFILM CORPORATION
DR-ID 800 IU DV3 E
In Commercial Distribution

  • 04547410457704 ()

  • 169×326×230mm


  • Stationary basic diagnostic x-ray system, digital

D-EVOIII C25i - 04547410445503

The DR-ID 1811SE, DR-ID 1812SE and DR-ID 1814SE incorporate a CsI indirect panel. The indirect-conversion flat panel sensor is a device which acquires a general radiograph.
FUJIFILM CORPORATION
DR-ID 1814 SE E
In Commercial Distribution

  • 04547410445503 ()

  • 333x282x15mm


  • Stationary basic diagnostic x-ray system, digital

D-EVOIII C43i - 04547410445480

The DR-ID 1811SE, DR-ID 1812SE and DR-ID 1814SE incorporate a CsI indirect panel. The indirect-conversion flat panel sensor is a device which acquires a general radiograph.
FUJIFILM CORPORATION
DR-ID 1812 SE E
In Commercial Distribution

  • 04547410445480 ()

  • 460x460x15mm


  • Stationary basic diagnostic x-ray system, digital

D-EVOIII C35i - 04547410445466

The DR-ID 1811SE, DR-ID 1812SE and DR-ID 1814SE incorporate a CsI indirect panel. The indirect-conversion flat panel sensor is a device which acquires a general radiograph.
FUJIFILM CORPORATION
DR-ID 1811 SE E
In Commercial Distribution

  • 04547410445466 ()

  • 460x384x15mm


  • Stationary basic diagnostic x-ray system, digital

D-EVOIII G43i - 04547410445442

The DR-ID 1831SE and DR-ID 1832SE incorporate a GOS indirect panel. The indirect-conversion flat panel sensor is a device which acquires a general radiograph.
FUJIFILM CORPORATION
DR-ID 1832 SE E
In Commercial Distribution

  • 04547410445442 ()

  • 460x460x15mm


  • Stationary basic diagnostic x-ray system, digital

D-EVOIII G35i - 04547410445428

The DR-ID 1831SE and DR-ID 1832SE incorporate a GOS indirect panel. The indirect-conversion flat panel sensor is a device which acquires a general radiograph.
FUJIFILM CORPORATION
DR-ID 1831 SE E
In Commercial Distribution

  • 04547410445428 ()

  • 460x384x15mm


  • Stationary basic diagnostic x-ray system, digital

FDR D-EVOIII Battery Pack S - 04547410436983

A battery pack for the flat panel sensor.
FUJIFILM CORPORATION
DR1800 SE BATTERY S E
In Commercial Distribution

  • 04547410436983 ()


  • Stationary basic diagnostic x-ray system, digital

FDR D-EVOII Battery Charger - 04547410431599

A battery charger for the battery pack.
FUJIFILM CORPORATION
DR1200 SE BATTERY CHARGER B E
In Commercial Distribution

  • 04547410431599 ()


  • Stationary basic diagnostic x-ray system, digital

FDR D-EVOIII Battery Pack - 04547410426922

A battery pack for the flat panel sensor.
FUJIFILM CORPORATION
DR1800 SE BATTERY E
In Commercial Distribution

  • 04547410426922 ()


  • Stationary basic diagnostic x-ray system, digital

D-EVOIII G43 - 04547410426915

The DR-ID 1801SE and DR-ID 1802SE incorporate a GOS indirect panel. The indirect-conversion flat panel sensor is a device which acquires a general radiograph.
FUJIFILM CORPORATION
DR-ID 1802 SE E
In Commercial Distribution

  • 04547410426915 ()

  • 460x460x15mm


  • Stationary basic diagnostic x-ray system, digital

D-EVOIII G35 - 04547410426908

The DR-ID 1801SE and DR-ID 1802SE incorporate a GOS indirect panel. The indirect-conversion flat panel sensor is a device which acquires a general radiograph.
FUJIFILM CORPORATION
DR-ID 1801 SE E
In Commercial Distribution

  • 04547410426908 ()

  • 460x384x15mm


  • Stationary basic diagnostic x-ray system, digital

FDR ES C43 - 04547410361377

The Wired/Wireless FDR ES (DR-ID1270) flat panel sensor system is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications including pediatric and neonatal exams wherever conventional film/screen or CR systems may be used. It is not intended for mammography, fluoroscopy, tomography, and angiography applications.
FUJIFILM CORPORATION
DR-ID 1274 SE E
In Commercial Distribution

  • 04547410361377 ()

  • 460x460x15mm


  • Stationary basic diagnostic x-ray system, digital
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