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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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B-Right Screen Fetal Heart - 03760415600000

Fetal EchoScan is a machine learning-based decision support system, indicated as an adjunct to fetal ultrasound examination in pregnant women anatomic ultrasound exams.
BRIGHTHEART
V1.0.0
In Commercial Distribution

  • 03760415600000 ()


  • Ultrasound imaging system application software

AHI System - B823AHIV200

The AHI System is an adjunctive monitoring method to enable identification of patients who are showing signs of hemodynamic instability or are likely to experience a future episode of hemodynamic instability, and to allow clinicians an opportunity to increase vigilance.
Fifth Eye, Inc.
2
In Commercial Distribution

  • B823AHIV200 ()


  • Clinical management support software

Analytic for Hemodynamic Instability - B823AHIP100

Analytic for Hemodynamic Instability(AHI) provides adjunctive hemodynamic status information to support clinical decision-making
Fifth Eye, Inc.
P1
In Commercial Distribution

  • B823AHIP100 ()


  • Clinical management support software

iQ®200 - 10837461002475

iQ®200 Body Fluids Module (CD only)
BECKMAN COULTER IRELAND INC.
Body Fluids Module
In Commercial Distribution

  • 10837461002475 ()
800-3704

  • Laboratory instrument/analyser application software IVD

NA - 04055207057537

DRIVER HF UNIT KLS MARTIN
Richard Wolf GmbH
5592606
Not in Commercial Distribution

  • 04055207057537 ()
5592606

  • Operating room audiovisual data/device management system application software

Vscan - 00195278640574

Vscan Air R2 Upgrade kit
GE Vingmed Ultrasound AS
Air R2 CL
In Commercial Distribution

  • 00195278640574 ()


  • Ultrasound imaging system application software

Vscan - 00195278640567

Vscan Air R2 for Android
GE Vingmed Ultrasound AS
Air R2 for Android
In Commercial Distribution

  • 00195278640567 ()


  • Ultrasound imaging system application software

Vscan - 00195278640550

Vscan Air R2 for iOS
GE Vingmed Ultrasound AS
Air R2 for iOS
In Commercial Distribution

  • 00195278640550 ()


  • Ultrasound imaging system application software

EchoPAC - 00195278504326

MD EchoPAC Plug-in v206
GE Vingmed Ultrasound AS
Plug-in v206
In Commercial Distribution

  • 00195278504326 ()


  • Ultrasound imaging system application software

Vscan - 00195278884749

Vscan Air R3 for iOS
GE Vingmed Ultrasound AS
Air R3 for iOS
In Commercial Distribution

  • 00195278884749 ()


  • Ultrasound imaging system application software
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