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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
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