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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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Ultima System CPX
MEDICAL GRAPHICS CORPORATION
800810-021
In Commercial Distribution

800810-021

  • Cardiopulmonary stress exercise monitoring system
Ultima System CPX - 120V UPS
MEDICAL GRAPHICS CORPORATION
800810-011
In Commercial Distribution

800810-011

  • Cardiopulmonary stress exercise monitoring system
Ultima System CPX
MEDICAL GRAPHICS CORPORATION
800810-001
In Commercial Distribution

800810-001

  • Cardiopulmonary stress exercise monitoring system
Express Series CCM
MEDICAL GRAPHICS CORPORATION
700023-906
In Commercial Distribution

700023-906

  • Cardiopulmonary stress exercise monitoring system
Express Series CCM
MEDICAL GRAPHICS CORPORATION
700023-905
In Commercial Distribution

700023-905

  • Cardiopulmonary stress exercise monitoring system
This device is intended for use in clinical and research application to measure oxygen uptake.
C O S M E D SRL
Fitmate GS
In Commercial Distribution

  • 18052400180362 ()


  • Indirect calorimeter
This device is intended for use in clinical and research application to measure oxygen uptake. Fitmate Pro is designed for the measurement of Resting Metabolic Rate and maximal oxygen uptake (VO2max) that is used for assessing basic pulmonary function.
C O S M E D SRL
Fitmate Pro
In Commercial Distribution

  • 18052400180225 ()


  • Cardiopulmonary stress exercise monitoring system
This device is intended for use in clinical and research application to measure oxygen uptake.
C O S M E D SRL
Fitmate Med
In Commercial Distribution

  • 18052400180249 ()


  • Cardiopulmonary stress exercise monitoring system
The device is intended for use in clinical and research application to measure oxygen uptake. Fitmate is designed for the measurement of Resting Metabolic Rate only.
C O S M E D SRL
Fitmate
In Commercial Distribution

  • 18052400180201 ()


  • Indirect calorimeter
No Description
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
689361
Not in Commercial Distribution

  • 50886333693615 ()
  • 00886333693610 ()
689361

  • Arterial blood sampling kit
Septum set connected with a 10cc syringe with touchguard stops at 10cc and a 60" Pressure tubing & a 3" small bore tube.
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
688695
In Commercial Distribution

  • 50886333686952 ()
  • 00886333686957 ()

  • 10cc syringe stops at 10cc with a 60" pressure tube
688695

  • Invasive-pressure external transducer, single-use
single pack TA-BPN for blood sampling
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
682159
In Commercial Distribution

  • 50886333621595 ()
  • 00886333621590 ()
682159

  • Arterial blood sampling kit
A Safedraw Septum connected to a 5cc Restricted Syringe stops at 2cc via a 60” Pressure Tubing. It has a 12” Pressure tubing on the patient side and a colour set.
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
682145
In Commercial Distribution

  • 50886333621458 ()
  • 00886333621453 ()

  • septum with 5cc syringe stops at 2cc
682145

  • Arterial blood sampling kit
A Safedraw Septum connected to a 5cc Restricted Syringe stops at 2cc via a 48” Pressure Tubing. It has a 12” Pressure tubing on the patient side and a colour set.
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
682144
In Commercial Distribution

  • 50886333621441 ()
  • 00886333621446 ()

  • 5cc restricted syringe stops at 2cc
682144

  • Arterial blood sampling kit
A Safedraw Septum connected to a 3cc Restricted Syringe stops at 2cc via a 48” Pressure Tubing. It has a 12” Pressure tubing on the patient side and a colour set.
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
682136
In Commercial Distribution

  • 50886333621366 ()
  • 00886333621361 ()

  • 3cc restricted syringe stops at 2cc
682136

  • Arterial blood sampling kit
A Safedraw Septum connected to a 3cc Restricted Syringe stops at 2cc via a 60” Pressure Tubing. It has a 12” Pressure tubing on the patient side and a colour set.
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
682135
In Commercial Distribution

  • 50886333621359 ()
  • 00886333621354 ()

  • 3cc restricted syringe stops at 2cc
682135

  • Arterial blood sampling kit
NGDS FilmArray Configuration kit (no computer included).
BIOFIRE DEFENSE, LLC
NGDS-ASY-0004
In Commercial Distribution

  • 00851458005143 ()
NGDS-ASY-0004

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Radiological computer assisted detection and diagnosis software
THERAPIXEL
MAL2US
In Commercial Distribution

  • B885MAML2US0 ()


  • X-ray image interpretive software
Radiological computer assisted detection and diagnosis software
THERAPIXEL
MAML
In Commercial Distribution

  • B885MAML0 ()
MAML

  • X-ray image interpretive software
BD FocalPoint™ GS Review Station Computer
BECTON, DICKINSON AND COMPANY
490189
In Commercial Distribution

  • 00382904901899 ()

  • Height: 33.2 Centimeter
  • Width: 55 Centimeter
  • Length: 59.2 Centimeter
490189

  • Cell morphology analyser IVD, manual
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