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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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The Aquanet APS-100 is a colon hydrotherapy device. It introduces water at a comfortable temperature into the large intestine. It is a system for filling and emptying water into and out of the colon and thus cleansing the colon of its contents when medically indicated such as before radiological or endoscopic examination.
Prime Pacific Health Innovations Corporation
APS-100
In Commercial Distribution

  • 07540198000107 ()
4305

  • Colonic lavage unit
The HotDog Warming Mattress + Return Electrode (“Mattress”) is part of a thermal regulating system, indicated for controlling patient temperature in adult patients. Mattresses utilize a flexible semi-conductive polymer fabric which warms the patient effectively within safe limits (controlled temperature, low watt density, low thermal mass) from a controller and sensor feedback loop. They are RF sealed in durable urethane shells designed to eliminate uncleanable crevices. Via a blue cable, they are powered with a low voltage floating isolated DC current, designed to safely operate in the most demanding clinical settings. Mattresses contain a green cable which enables the mattress to function as a capacitive return electrode for electrosurgery.
AUGUSTINE TEMPERATURE MANAGEMENT LLC
U530
In Commercial Distribution

  • 00855913001848 ()
U530

  • Electric pad whole-body heating system
  • Electrosurgical return electrode, reusable
The HotDog Warming Mattress + Return Electrode (“Mattress”) is part of a thermal regulating system, indicated for controlling patient temperature in adult patients. Mattresses utilize a flexible semi-conductive polymer fabric which warms the patient effectively within safe limits (controlled temperature, low watt density, low thermal mass) from a controller and sensor feedback loop. They are RF sealed in durable urethane shells designed to eliminate uncleanable crevices. Via a blue cable, they are powered with a low voltage floating isolated DC current, designed to safely operate in the most demanding clinical settings. Mattresses contain a green cable which enables the mattress to function as a capacitive return electrode for electrosurgery.
AUGUSTINE TEMPERATURE MANAGEMENT LLC
U502
In Commercial Distribution

  • 00855913001824 ()
U502

  • Electric pad whole-body heating system
  • Electrosurgical return electrode, reusable
The HotDog Warming Mattress + Return Electrode (“Mattress”) is part of a thermal regulating system, indicated for controlling patient temperature in adult patients. Mattresses utilize a flexible semi-conductive polymer fabric which warms the patient effectively within safe limits (controlled temperature, low watt density, low thermal mass) from a controller and sensor feedback loop. They are RF sealed in durable urethane shells designed to eliminate uncleanable crevices. Via a blue cable, they are powered with a low voltage floating isolated DC current, designed to safely operate in the most demanding clinical settings. Mattresses contain a green cable which enables the mattress to function as a capacitive return electrode for electrosurgery.
AUGUSTINE TEMPERATURE MANAGEMENT LLC
U501
In Commercial Distribution

  • 00855913001817 ()
U501

  • Electric pad whole-body heating system
  • Electrosurgical return electrode, reusable
GPRO P1,Gutta-percha Obturation Heating Pen Tips included: 40mm/04 taper, 45mm/04 taper, 55mm/06 taper, 55mm/08 taper
Beyes Dental Canada Inc
GP2003
In Commercial Distribution

  • 00990010302211 ()
GPRO P1

  • Endodontic obturation system handpiece, heat conducting
GPRO P1,Gutta-percha Obturation Heating Pen Tips included: 40mm/04 taper, 45mm/04 taper, 55mm/06 taper, 55mm/08 taper
Beyes Dental Canada Inc
GP2003
In Commercial Distribution

  • 00837699001021 ()


  • Endodontic obturation system handpiece, heat conducting
No Description
Multi Radiance Medical
MR4 LaserStim Emitter G
In Commercial Distribution

  • 00852556007213 ()
650-108G

  • Musculoskeletal infrared phototherapy unit, non-wearable
No Description
Multi Radiance Medical
TQ LaserStim Emitter
In Commercial Distribution

  • 00852556007138 ()
850-108

  • Musculoskeletal infrared phototherapy unit, non-wearable
No Description
Multi Radiance Medical
MR4 LaserStim Emitter
In Commercial Distribution

  • 00852556007039 ()
650-108

  • Musculoskeletal infrared phototherapy unit, non-wearable
RecoveryAir JetBoots Pro is a pair of pneumatic compression boots that incorporate vibration and IR technologies. These new features will enhance recovery of legs throughout their combination in different preset programs. The device is designed to work in pairs with a master boot, with a main control panel, and a dummy boot. Additionally, it will be Bluetooth enabled to connect with the Therabody App where user can access to more settings, presets, and track overall usage
Therabody, Inc.
JetBoots PRO Plus Long
In Commercial Distribution

  • 00840295405582 ()


  • Sequential venous compression system inflator
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