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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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SonoCiné Image Acquisition Station Model 201, PN 501775000 is an accessory to ultrasound imaging Systems facilitating their use as an adjunct to mammography for B-mode ultrasonic screening imaging of the breast when used with a linear array transducer consisting of the following components: Image Acquisition Station Model 201 – PN 501775-000, Image Acquisition Station Software Application V3.1.x, PN 501642, Reading Station Software Application, V3.1.x, PN 501973.
SONOCINE, INC.
Model 201
In Commercial Distribution

  • B3015017750001 ()
501775000

  • Breast ultrasound imaging system
The Caption Guidance software is intended to assist medical professionals in the acquisition of cardiac ultrasound images. Caption Guidance software is an accessory to compatible general purpose diagnostic ultrasound systems. Caption Guidance software is indicated for use in two-dimensional transthoracic echocardiography (2D-TTE) 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).
CAPTION HEALTH, INC.
Apollo
In Commercial Distribution

  • 00860003586334 ()
511-00021

  • Ultrasound imaging system application software
KENDALL DL DISPOSABLE DRAEGER DIRECT CO
MEDLINE INDUSTRIES, INC.
33132R
In Commercial Distribution

  • 40888277313119 ()
  • 10888277313118 ()
33132R

  • Electrocardiographic lead set, reprocessed
GE to 4 Pin CO Cable
Advantage Medical Electronics, LLC
CB-92064
In Commercial Distribution

  • 00849593022262 ()


  • Electrical-only medical device connection cable, reusable
AirCurve 10 ST USA C2C CO
RESMED PTY LTD
37385
In Commercial Distribution

  • 00619498373857 ()
37385

  • Portable electric ventilator
AirCurve 10 ASV USA C2C CO
RESMED PTY LTD
37384
In Commercial Distribution

  • 00619498373840 ()
37384

  • Home BPAP unit
AirCurve 10 VAUTO USA C2C CO
RESMED PTY LTD
37383
In Commercial Distribution

  • 00619498373833 ()
37383

  • Portable electric ventilator
AirSense 10 AutoSet NA C2C CO
RESMED PTY LTD
37382
In Commercial Distribution

  • 00619498373826 ()
37382

  • Home CPAP unit
AirCurve 10 ST-A USA C2C CO
RESMED PTY LTD
28285
In Commercial Distribution

  • 00619498282852 ()
28285

  • Home BPAP unit
MTO,3V,PMM-LITTLE,CO,OF MARY-PG
MEDLINE INDUSTRIES, INC.
65120646
In Commercial Distribution

  • 10193489061383 ()
  • 20193489061380 ()
65120646

  • Angiography kit
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