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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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Adapter for QuikLinq FOB
MEDSPIRA, LLC
RMD-210-020
In Commercial Distribution

  • 10851607003003 ()
  • 00851607003006 ()


  • Manometric gastrointestinal motility analysis system
100cc Syringe, Luer-Locking, 5-Pack
MEDSPIRA, LLC
RMD-010-017
In Commercial Distribution

  • 10851607003539 ()
  • 00851607003532 ()


  • Manometric gastrointestinal motility analysis system
Battery for Tablet PC
MEDSPIRA, LLC
RMD-010-009
In Commercial Distribution

  • 00851607003525 ()
  • 10851607003522 ()


  • Manometric gastrointestinal motility analysis system
Syringe, Luer-Locking, 100cc, 5-Pack
MEDSPIRA, LLC
RMD-010-016
In Commercial Distribution

  • 10851607003515 ()
  • 00851607003518 ()


  • Manometric gastrointestinal motility analysis system
AC Power Cable, 3-Prong, US
MEDSPIRA, LLC
RMD-010-003
In Commercial Distribution

  • 10851607003492 ()
  • 00851607003495 ()


  • Manometric gastrointestinal motility analysis system
mcompass Anorectal Manometry System
MEDSPIRA, LLC
RMD-001U
In Commercial Distribution

  • 10851607003393 ()
  • 00851607003396 ()


  • Manometric gastrointestinal motility analysis system
Accessories for mcompass systems
MEDSPIRA, LLC
RMD-010-011
In Commercial Distribution

  • 10851607003386 ()
  • 00851607003389 ()


  • Manometric gastrointestinal motility analysis system
Medspira Tablet PC with Power Supply
MEDSPIRA, LLC
RMD-010-010
In Commercial Distribution

  • 10851607003379 ()
  • 00851607003372 ()


  • Manometric gastrointestinal motility analysis system
Battery for FOB
MEDSPIRA, LLC
RMD-010-009
In Commercial Distribution

  • 10851607003362 ()
  • 00851607003365 ()


  • Manometric gastrointestinal motility analysis system
No Description
MEDSPIRA, LLC
RMD-010-004
In Commercial Distribution

  • 10851607003317 ()
  • 00851607003310 ()


  • Manometric gastrointestinal motility analysis system
No Description
MEDSPIRA, LLC
RMD-010-008
In Commercial Distribution

  • 00851607003297 ()


  • Manometric gastrointestinal motility analysis system
No Description
MEDSPIRA, LLC
RMD-001-TAB
In Commercial Distribution

  • 00851607003280 ()
  • 10851607003287 ()


  • Manometric gastrointestinal motility analysis system
Medspira Anorectal Manometry and Biofeedback System
MEDSPIRA, LLC
RMD-003
In Commercial Distribution

  • 00851607003273 ()
  • 10851607003270 ()


  • Manometric gastrointestinal motility analysis system
No Description
MEDSPIRA, LLC
RMD-010-007
In Commercial Distribution

  • 00851607003266 ()
  • 10851607003263 ()


  • Manometric gastrointestinal motility analysis system
No Description
MEDSPIRA, LLC
RMD-010-006
In Commercial Distribution

  • 00851607003259 ()
  • 10851607003256 ()


  • Manometric gastrointestinal motility analysis system
No Description
MEDSPIRA, LLC
RMD-010-005
In Commercial Distribution

  • 00851607003242 ()
  • 10851607003249 ()


  • Manometric gastrointestinal motility analysis system
No Description
MEDSPIRA, LLC
RMD-002-MON
In Commercial Distribution

  • 00851607003235 ()
  • 10851607003232 ()


  • Manometric gastrointestinal motility analysis system
No Description
MEDSPIRA, LLC
RMD-002-COM
In Commercial Distribution

  • 00851607003228 ()
  • 10851607003225 ()


  • Manometric gastrointestinal motility analysis system
No Description
MEDSPIRA, LLC
RMD-002-001
In Commercial Distribution

  • 00851607003211 ()


  • Manometric gastrointestinal motility analysis system
No Description
MEDSPIRA, LLC
RMD-001-003
In Commercial Distribution

  • 00851607003204 ()


  • Manometric gastrointestinal motility analysis system
No Description
MEDSPIRA, LLC
RMD-002-VGA
In Commercial Distribution

  • 00851607003174 ()
  • 10851607003171 ()


  • Manometric gastrointestinal motility analysis system
No Description
MEDSPIRA, LLC
RMD-010-001
In Commercial Distribution

  • 00851607003143 ()


  • Manometric gastrointestinal motility analysis system
No Description
MEDSPIRA, LLC
RMD-002-POUCH
In Commercial Distribution

  • 00851607003099 ()
  • 10851607003096 ()


  • Manometric gastrointestinal motility analysis system
Medspira Biofeedback Anorectal Manometry System
MEDSPIRA, LLC
RMD-002
In Commercial Distribution

  • 10851607003065 ()
  • 00851607003068 ()
RMD-002

  • Manometric gastrointestinal motility analysis system
Medspira mcompass Diagnostic Anorectal Manometry system
MEDSPIRA, LLC
RMD-001
In Commercial Distribution

  • 10851607003058 ()
  • 00851607003051 ()
RMD-001

  • Manometric gastrointestinal motility analysis system
Medspira mcompass Anorectal Manometry FOB
MEDSPIRA, LLC
RMD-001-001
In Commercial Distribution

  • 00851607003044 ()
  • 10851607003041 ()
RMD-001-001

  • Manometric gastrointestinal motility analysis system
The HeartFlow Analysis is AI-based medical device software developed for the clinical quantitative and qualitative analysis of CT DICOM data. It is a tool for the analysis of CT DICOM-compliant cardiac images and data, to assess the anatomy and function of the coronary arteries in the risk stratification and evaluation of coronary artery disease. The software displays coronary anatomy and functional information using graphics and text, including computed and derived quantities of percent stenosis, plaque volumes, blood flow, pressure and velocity, to aid the clinician in the assessment and treatment planning of coronary artery disease. The HeartFlow Analysis is performed on previously physician-acquired image data and are unrelated to acquisition equipment and clinical workstations.
Heartflow, Inc.
FFRct version 3
In Commercial Distribution

  • 00853341006060 ()


  • Vascular modelling software
The HeartFlow Analysis is coronary physiologic simulation software developed for the clinical quantitative and qualitative analysis of CT DICOM data. It is a tool for the analysis of CT DICOM-compliant cardiac images and data, to assess the anatomy and function of the coronary arteries. The software displays the anatomy combined with functional information using graphics and text, including computed and derived quantities of blood flow, pressure and velocity, to aid the clinician in the assessment and treatment planning of coronary artery disease. The HeartFlow Analysis is performed on previously physician-acquired image data and are unrelated to acquisition equipment and clinical workstations.
Heartflow, Inc.
FFRct version 3
In Commercial Distribution

  • 00853341006053 ()


  • Vascular modelling software
The HeartFlow Analysis is coronary physiologic simulation software developed for the clinical quantitative and qualitative analysis of CT DICOM data. It is a tool for the analysis of CT DICOM-compliant cardiac images and data, to assess the anatomy and function of the coronary arteries. The software displays the anatomy combined with functional information using graphics and text, including computed and derived quantities of blood flow, pressure and velocity, to aid the clinician in the assessment and treatment planning of coronary artery disease. The HeartFlow Analysis is performed on previously physician-acquired image data and are unrelated to acquisition equipment and clinical workstations.
Heartflow, Inc.
FFRct version 2
In Commercial Distribution

  • 00853341006039 ()


  • Vascular modelling software
HeartFlow FFRct is coronary physiologic simulation software developed for the clinical quantitative and qualitative analysis of CT DICOM data. It is a tool for the analysis of CT DICOM-compliant cardiac images and data, to assess the anatomy and function of the coronary arteries. The software displays the anatomy combined with functional information using graphics and text, including computed and derived quantities of blood flow, pressure and velocity, to aid the clinician in the assessment of coronary artery disease. FFRct is independent of imaging equipment, imaging protocols and equipment vendors; the clinical validation report includes identification of vendors and equipment used in the clinical validation of the product. This data is summarized in the product labeling, and can be found in the Clinical User Instructions for Use. HeartFlow FFRct analyses are performed on previously physician-acquired image data and are unrelated to acquisition equipment and clinical workstations.
Heartflow, Inc.
v2.18
In Commercial Distribution

  • 00853341006022 ()


  • Vascular modelling software
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