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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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XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module with Trigger Module for TTL/analog signal output; Turnkey system with configured CPU and color LCD 24" monitor with 1920 x 1080 resolution; No power cord; No printer, basic laser transport cart with base and back panel; AHA 10 wire, 12-lead lead set with medi-clips; Isolation transformer 1000 VA Med Global; Report Export + XML Orders (requir
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094326611 ()
XSCRIBE-6AD-XEAAA

  • Cardiopulmonary stress exercise monitoring system computer
XScribe Cardiac Stress - ver 6 w/ adult & pediatric interp; includes current sfw CD & User Manual CD; AM12 Wired Acquisition Module; Turnkey system w/ configured CPU & color LCD 24" monitor w/ 1920 x 1080 res; UK pwr cord; Z200+ thermal printer(includes starter pack of full-grid paper - A4), XScribe basic transport cart w/ base, back panel, & keyboard tray; IEC 10 wire, 12-lead lead set w/ medi-clips; Isolation transformer 1000 VA Med Global; Report Export + DICOM bidirectional Interface
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094320183 ()
XSCRIBE-6DD-CDBAB

  • Cardiopulmonary stress exercise monitoring system computer
The Oxygen Generator and Liquefier (OGL) is a portable oxygen generating and liquefaction system, capable of producing up to 15 liters per minute of gaseous 93% USP oxygen for medical use or 1 liter of LOX per hour. Up to 40 liters of LOX can be stored in the internal tank until needed. The system features a user-friendly control panel and an insulated transfer hose which will work with any portable LOX device having a standard CRU-50 fill connection.
ESSEX INDUSTRIES, INC.
50C-0103-5
In Commercial Distribution

  • 10815363020001 ()
50C-0103-5

  • Mobile/portable oxygen concentrator
The Oxygen Generator and Liquefier (OGL) is a portable oxygen generating and liquefaction system, capable of producing up to 15 liters per minute of gaseous 93% USP oxygen for medical use or 1 liter of LOX per hour. Up to 40 liters of LOX can be stored in the internal tank until needed. The system features a user-friendly control panel and an insulated transfer hose which will work with any portable LOX device having a standard CRU-50 fill connection.
ESSEX INDUSTRIES, INC.
50C-0103-7
In Commercial Distribution

  • 10815363020018 ()
50C-0103-7

  • Mobile/portable oxygen concentrator
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
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 Regular
In Commercial Distribution

  • 00840295405575 ()


  • Sequential venous compression system inflator
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 Short
In Commercial Distribution

  • 00840295405568 ()


  • Sequential venous compression system inflator
The DR-XD 3000 is a mobile C-arm system with detachable flat panel detector, which is intended for use in providing medical imaging for general populations including pediatrics. The device provides pulsed fluoroscopic imaging of patients during diagnostic, interventional and surgical procedures and digital radiographic imaging. It is intended for use in procedures such as holangiography, endoscopic, urologic, orthopedic, neurologic, critical care, peripheral vascular, emergency room procedures. This device does not support cardiac procedures and is not intended for use in performing mammography.
FUJIFILM CORPORATION
DR-XD 3000
In Commercial Distribution

  • 04547410467710 ()


  • Mobile general-purpose fluoroscopic x-ray system, digital
The AVACEN HOME XL consists of a control panel, temperature controlled raised thermal transfer pad, and a vacuum chamber. The AVACEN HOME XL is designed to comfortably and noninvasively apply dry heat to the hand for the temporary relief of minor aches and pains. The user places their hand into the AVACEN HOME XL for approximately 10 to 60 minutes per treatment session. A vacuum pump creates a slight vacuum (25 to 35mm Hg) on the hand, which accelerates the transfer of heat.
AVACEN MEDICAL, INC
AVACEN HOME XL 5-YEAR
In Commercial Distribution

  • 00862800000396 ()


  • Electric pad localized-body heating system
The AVACEN HOME XL consists of a control panel, temperature controlled raised thermal transfer pad, and a vacuum chamber. The AVACEN HOME XL is designed to comfortably and noninvasively apply dry heat to the hand for the temporary relief of minor aches and pains. The user places their hand into the AVACEN HOME XL for approximately 10 to 60 minutes per treatment session. A vacuum pump creates a slight vacuum (25 to 35mm Hg) on the hand, which accelerates the transfer of heat.
AVACEN MEDICAL, INC
AVACEN HOME XL 3-YEAR
In Commercial Distribution

  • 00862800000372 ()


  • Electric pad localized-body heating system
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