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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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CAPTION HEALTH, INC.
Alastor
In Commercial Distribution

  • 00860003586341 ()


  • Ultrasound imaging system application software
Caption AI (Caption Guidance + Caption Interpretation) on portable handheld ultrasound. The Caption Guidance software is indicated for use in two-dimensional transthoracic echocardiography (2DTTE) for adult patients, specifically in the acquisition of the following standard views: Parasternal Long-Axis (PLAX), Parasternal Short-Axis at the Aortic Valve (PSAX-AV), Parasternal Short-Axis at the Mitral Valve (PSAX-MV), Parasternal Short-Axis at the Papillary Muscle (PSAX-PM), Apical 4-Chamber (AP4), Apical 5- Chamber (AP5), Apical 2-Chamber (AP2), Apical 3-Chamber (AP3), Subcostal 4-Chamber (SubC4), and Subcostal Inferior Vena Cava (SC-IVC). The Caption Interpretation Automated Ejection Fraction software is used to process previously acquired transthoracic cardiac ultrasound images, to store images, and to manipulate and make measurements on images using an ultrasound device, personal computer, or a compatible DICOM-compliant PACS system in order to provide automated estimation of left ventricular ejection fraction. This measurement can be used to assist the clinician in a cardiac evaluation. The Caption Interpretation Automated Ejection Fraction Software is indicated for use in adult patients.
CAPTION HEALTH, INC.
Adonis
In Commercial Distribution

511-00019

  • Ultrasound imaging system application software
The Caption Guidance software is indicated for use in two-dimensional transthoracic echocardiography (2DTTE) for adult patients, specifically in the acquisition of the following standard views: Parasternal Long-Axis (PLAX), Parasternal Short-Axis at the Aortic Valve (PSAX-AV), Parasternal Short-Axis at the Mitral Valve (PSAX-MV), Parasternal Short-Axis at the Papillary Muscle (PSAX-PM), Apical 4-Chamber (AP4), Apical 5- Chamber (AP5), Apical 2-Chamber (AP2), Apical 3-Chamber (AP3), Subcostal 4-Chamber (SubC4), and Subcostal Inferior Vena Cava (SC-IVC). The Caption Interpretation Automated Ejection Fraction software is used to process previously acquired transthoracic cardiac ultrasound images, to store images, and to manipulate and make measurements on images using an ultrasound device, personal computer, or a compatible DICOM-compliant PACS system in order to provide automated estimation of left ventricular ejection fraction. This measurement can be used to assist the clinician in a cardiac evaluation. The Caption Interpretation Automated Ejection Fraction Software is indicated for use in adult patients.
CAPTION HEALTH, INC.
0.10, 0.11, 1.1, 1.2, 1.3, 1.4
Not in Commercial Distribution

  • 00860003586303 ()
511-00003

  • Ultrasound imaging system application software
Multi-link cable for connecting data acquisition unit
NIHON KOHDEN CORPORATION
YS-096P5
In Commercial Distribution

  • 04931921114742 ()
YS-096P5

  • General-purpose multi-parameter bedside monitor
Multi-link cable for connecting data acquisition unit
NIHON KOHDEN AMERICA, INC.
YS-096P5
In Commercial Distribution

  • 00841983101885 ()
YS-096P5

  • General-purpose multi-parameter bedside monitor
TekDAQ 200 Wearable Sensor Data Acquisition Device
Tekscan, Inc.
TekDAQ 200
In Commercial Distribution

  • B970TD2000 ()
TD-200

  • Body-surface pressure mapping system
SHEATH,HF,W/STAB,2 STPCK F/4MM STORZ SCP
ARTHREX, INC.
AR-3016Q
In Commercial Distribution

  • 00888867100343 ()
AR-3016Q

  • Endoscope sheath, reusable
BLUNT F/TAP/FEN HF PANO SCP SHTH W/HDLE
ARTHREX, INC.
AR-3375-4204
In Commercial Distribution

  • 00888867431324 ()
AR-3375-4204

  • Orthopaedic trocar blade, reusable
TROCAR F/ TAP/FEN,HF PANO SCP SHTH W/HDL
ARTHREX, INC.
AR-3375-4202
In Commercial Distribution

  • 00888867431300 ()
AR-3375-4202

  • Laparoscopic trocar blade, reusable
PowerPICC SOLO2 HF Catheter 5F Triple-Lumen Full Kit (55 cm)
Bard Access Systems, Inc.
3395108Q
In Commercial Distribution

  • 10801741028349 ()
  • 00801741028342 ()

  • Length: 55 Centimeter
  • Catheter Gauge: 5 French
3395108Q

  • Peripherally-inserted central venous catheter
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