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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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A comprehensive range of Salmonella slide agglutination antisera in 3.0 ml dropper bottles with shelf lives up to five years from date of manufacture. The range includes a full panel of polyvalent somatic antisera, monovalent somatic antisera, polyvalent flagella antisera and monovalent flagella antisera for traditional slide agglutination testing. Also available are a range of rapid Salmonella diagnostic sera (RSD) for the initial identification of primary groups of Salmonella. All antisera are presented in colour coded dropper bottles.
PRO-LAB, INCORPORATED
PL.6002
In Commercial Distribution

  • 05060472461926 ()
PL.6002

  • Multiple Salmonella species total antibody IVD, reagent
A comprehensive range of Salmonella slide agglutination antisera in 3.0 ml dropper bottles with shelf lives up to five years from date of manufacture. The range includes a full panel of polyvalent somatic antisera, monovalent somatic antisera, polyvalent flagella antisera and monovalent flagella antisera for traditional slide agglutination testing. Also available are a range of rapid Salmonella diagnostic sera (RSD) for the initial identification of primary groups of Salmonella. All antisera are presented in colour coded dropper bottles.
PRO-LAB, INCORPORATED
PL.6000
In Commercial Distribution

  • 05060472461919 ()
PL.6000

  • Multiple Salmonella species total antibody IVD, reagent
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
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
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
XScribe Cardiac Stress – ver 6 w/ adult and ped interp; w/ current sfw CD and User Manual CD; WAM Wireless Acquisition Module w/ Trigger Module for TTL/analog signal output; Turnkey system w/ config CPU and ELO brand capacitive color touchscreen 24" monitor w/ 1920 x 1080 res; UK pwr cord; Z200+ thermal printer(w/ starter pk of full-grid paper), basic transport cart/ base, back panel, and keyboard tray; IEC 10 wire, 12-lead lead set w/ medi-clips; Isolation transformer 1000 VA Med Global
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094319422 ()
XSCRIBE-6AB-CDBAA

  • Cardiopulmonary stress exercise monitoring system computer
A surgical and therapeutic device intended for a variety of soft tissue procedures as well as for use in providing temporary relief of minor pain. The system includes a laser console with a touch screen control panel/user interface, a wireless footswitch, a delivery system comprising of a fiber optic cable, two handpieces, and laser tips. Other system accessories include protective eyewear, power supply with power cords, screen protectors, and batteries. The patient-contacting components of the delivery system require sterilization prior to use.
Biolase, Inc.
7400054 Refurbished
In Commercial Distribution

  • 00647529002575 ()


  • General/multiple surgical diode laser system
A surgical and therapeutic device intended for a variety of soft tissue procedures as well as for use in providing temporary relief of minor pain. The system includes a laser console with a touch screen control panel/user interface, a wireless footswitch, a delivery system comprising of a fiber optic cable, two handpieces, and laser tips. Other system accessories include protective eyewear, power supply with power cords, screen protectors, and batteries. The patient-contacting components of the delivery system require sterilization prior to use.
Biolase, Inc.
7400054
In Commercial Distribution

  • 00647529000236 ()
7400054

  • General/multiple surgical diode laser system
An all-tissue dental laser system intended for a variety of soft-tissue and hard-tissue procedures. The system includes a top-table laser console with a removable tablet PC as a control panel/user interface, a delivery system comprising of a fiber optic cable, two handpieces and laser tips, and a wireless foot-switch. Other system components include protective eyewear, power cords, tip cleaning kit, tablet protective covers, water reservoir fill kit, etc. The patient-contacting components of the delivery system require sterilization prior to use.
Biolase, Inc.
7210001
Not in Commercial Distribution

  • 00647529002339 ()
7210001

  • Dental solid-state laser 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 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
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
HOME XL
In Commercial Distribution

  • 00862800000365 ()


  • Electric pad localized-body heating system
The AVACEN HOME+ consists of a control panel, temperature controlled raised thermal transfer pad, and a vacuum chamber. The AVACEN HOME+ 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+ for approximately 10 to 30 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+ 5-YEAR
In Commercial Distribution

  • 00862800000341 ()


  • Electric pad localized-body heating system
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 G5 Cellutec produces a non-invasive therapy treatment for skin, scalp, tissue, muscles, lymph nodes and the circulatory system. The Cellutec unit provides aesthetic services such as cellulite reduction, exfoliation, lymphatic drainage, body contouring, skin toning and muscle relaxation. Comes complete with caster stand, accessory tray, and Spa Treatment applicator package. Continuously-variable speed: 20-60 CPS. Unit Advantages: Versatility: Pole, Table Top and Wall Mountable Portability: In-mold handle and smooth casters to easily move from room to room CPS Indicator on Control Panel
GENERAL PHYSIOTHERAPY INC
CEL 24 W
In Commercial Distribution

  • 00746980000592 ()

  • Weight: 38 Pound
CEL 24 W

  • Freestanding electric massager
Radiography 7300 C is a high-end digital radiography system consisting of a height adjustable patient support table and a ceiling suspension consisting of a tube including a control handle used to acquire images with a flat panel fixed RAD detector. Additionally, different vertical stands for the radiography examinations are available. The ceiling suspension can be moved in longitudinal and lateral directions and additionally the tube can be tilted and rotated as well. The proposed Radiography 7300 C is configured with a Philips x-ray generator and a flat panel fixed RAD detector, Pixium 4343RCE. Together with the tube these components form the radiography Image Chain. The additional option of the portable wireless detector i.e. the SkyPlate family can be used for free exposures as well as in the patient support table or in the vertical stand. The proposed Radiography 7300 C uses the following Accessories, • Parking frame for accessories • Handgrips • Side Bar • Adjustable straps • Compression Belt • Infusion Bottle holder TH-S • Infusion Bottle holder TH2 • Support for CPR (Cardio Pulmonary Resuscitation) • Stretch Grip • Remote control holder • Charger 2EZ • Grid’s for Skyplayte Wireless Portable Detectors • Grid’s for Fixed Detectors • Detector Handle • Detector holder for patient bed • Mobile detector holder • Portable panel protector • WPD Hygienic bags • Patient support • Adjustable Straps for Patient Support • Stitching Ruler Radiography 7300C is a successor of DigitalDiagnost C90 (Release Version 1.1). The main differences of Radiography 7300 C versus DigitalDiagnost C90 are optional new features: • Assisted collimation & Assisted detector height alignment (Smart Collimation Thorax / SCT) • Overlays including On-screen collimation & AEC Visualization
Philips Medical Systems DMC GmbH
712037
In Commercial Distribution

  • 00884838116016 ()


  • Stationary basic diagnostic x-ray system, digital
An all-tissue dental laser system intended for a variety of oral soft-tissue and hard-tissue procedures. The system includes a top-table laser console with a removable tablet PC as a control panel/user interface, a wireless footswitch and a delivery system comprising of a fiber optic cable, two handpieces and a variety of laser tips. Other system components include protective eyewear, power cords, a tip cleaning kit, tablet protective covers, water reservoir fill kit, etc. The patient-contacting components of the delivery system require sterilization prior to use.
Biolase, Inc.
7210001
In Commercial Distribution

  • 00647529003534 ()
7210001

  • Dental solid-state laser system
An all-tissue dental laser system intended for a variety of oral soft-tissue and hard-tissue procedures. The system includes a top-table laser console with a removable tablet PC as a control panel/user interface, a wireless footswitch and a delivery system comprising of a fiber optic cable, two handpieces and a variety of laser tips. Other system components include protective eyewear, power cords, a tip cleaning kit, tablet protective covers, water reservoir fill kit, etc. The patient-contacting components of the delivery system require sterilization prior to use.
Biolase, Inc.
Waterlase Express laser refurbished
In Commercial Distribution

  • 00647529003466 ()
7210001P

  • Dental solid-state laser system
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