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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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For calibration of Blood Gas Analyzers in accordance with Manufacturers Instruction.
Roberts Oxygen Company, Inc.
1
In Commercial Distribution

  • 00860009502017 ()


  • Blood gas analyser IVD, point-of-care
  • Multiple blood gas analyte IVD, calibrator
Neurotrack’s exam is a computerized cognitive exam delivered via mobile device or browser, intended to detect and track cognitive impairment in patients with existing cognitive impairment, subjective memory loss, or healthy individuals. The user will interact with the exam battery on a screen. Using visual cues, the user will touch the screen, trackpad or mouse to make a selection. Successful completion of the exam battery relies on use of the hands and eyes. The device may be used by the patient in the home, or in a health clinic with or without supervision. The results are reviewed by a health care provider trained in nervous system conditions. Neurotrack’s digital cognitive assessment suite is not a stand-alone diagnostic tool and does not identify the absence or presence of any illness, condition, or disease. While Neurotrack’s digital cognitive assessment suite can be self-administered, any interpretation of scores should be discussed with a healthcare provider.
Neurotrack Technologies, Inc.
1.1.0
In Commercial Distribution

  • 00860009484504 ()


  • Cognitive assessment software
Plastic Tape Long, 1 in. x 10 yards
Markethatch Co., Inc.
PlasTapeLong
In Commercial Distribution

  • 00860009478732 ()

  • Length: 10 Yard
  • Width: 1 Inch
PlasTapeLong

  • Dressing-fixation skin adhesive tape, non-silicone
Paper Tape Long, 1 in. x 10 yards
Markethatch Co., Inc.
PapeTapeLong
In Commercial Distribution

  • 00860009478725 ()

  • Length: 10 Yard
  • Width: 1 Inch
PapeTapeLong

  • Dressing-fixation skin adhesive tape, non-silicone
Plastic Tape, 1 in. x 15 ft.
Markethatch Co., Inc.
PlasTape
In Commercial Distribution

  • 00860009478718 ()

  • Length: 15 Feet
  • Width: 1 Inch
PlasTape

  • Dressing-fixation skin adhesive tape, non-silicone
Paper Tape, 1 in. x 15 ft.
Markethatch Co., Inc.
PapeTape
In Commercial Distribution

  • 00860009478701 ()

  • Length: 15 Feet
  • Width: 1 Inch
PapeTape

  • Dressing-fixation skin adhesive tape, non-silicone
ABS plastic barrel electronic larynx provides users the ability to fully customize both volume and pitch. Never replace batteries again with its permanent Lithium-Ion battery. Charging is made simple with included magnetic USB charging cable. Includes either a country-specific or universal charging block.
Fountain Head Marketing Inc.
EL 2000
In Commercial Distribution

  • 00860009460591 ()


  • Voice amplification system
The R600 is the latest and modern electronic larynx model to hit the market. Being the most economical option out there, this artificial larynx is designed for the voice impaired adult providing countless benefits and modern improvements over other artificial larynx devices, including: Permanently installed Li-Ion battery saving you money on AA or AAA batteries. Gun metal electroplated Aluminum Barrel Installed Li-Ion battery offers a safer alternative to NiMH batteries. (NiMH depletes charge even when not in use) 30 hours of reliable speaking time. USB rechargeable. No batteries needed! USB charging cable, charging brick, and lanyard is included! Operating instructions, basic use, programming, battery information and more can be found in the Operating Instructions included with each box. Please be sure to consult with your SLP for the most optimal experience.
Fountain Head Marketing Inc.
R600
In Commercial Distribution

  • 00860009460546 ()


  • Voice amplification system
Get up to date with the latest electronic larynx device, the R700! The R700 is the latest and modern electronic larynx model to hit the market. Being the most economical option out there, this artificial larynx is designed for the voice impaired adult providing countless benefits and modern improvements over other artificial larynx devices, including: Volume and pitch controls to customize the sound just the way you want it. Permanently installed Li-Ion battery saving you money on AA or AAA batteries. Gun metal electroplated Aluminum Barrel Installed Li-Ion battery offers a safer alternative to NiMH batteries. (NiMH depletes charge even when not in use) 30 hours of reliable speaking time. USB rechargeable. No batteries needed! EU adapter, USB charging cable, charging brick, and lanyard is included! Operating instructions, basic use, programming, battery information and more can be found in the Operating Instructions included with each box.
Fountain Head Marketing Inc.
R700
In Commercial Distribution

  • 00860009460539 ()


  • Voice amplification system
After undergoing surgery for partial or total laryngectomy due to throat cancer or accidental damage to the larynx, with the consequent removal of the vocal cords, one is no longer able to speak. This condition is due to the absence of vibrations which were previously produced by the vocal cords. To overcome this challenge, there is no solution other than to artificially produce these vibrations. The ROMET Electronic Larynx or Electrolarynx, produces such vibrations and permits the user to emit clear and very comprehensible vocal sounds. The Romet Model R310 Electrolarynx Includes: 2 Year Warranty Delrin Barrel with Exclusive, New Soft-Grip Barrel w/Anti-Roll Feature Larger, Ergonomic On/Off Button External Pitch and Volume Controls Two-9V Lithium Batteries w/Smart Charger Lanyard (Important reminder - See a Speech Language Pathologist for help learning where to best use the device on your neck)
Fountain Head Marketing Inc.
R310
In Commercial Distribution

  • 00860009460522 ()


  • Voice amplification system
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