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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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Xhibit - 10841522100345

XHIBIT CENTRAL STATION,96102
SPACELABS HEALTHCARE (WASHINGTON), INC
96102
Not in Commercial Distribution

  • 10841522100345 ()
96102

  • Centralized patient monitor

qube mini - 10841522100239

QUBE MINI TRANSPORT MONITOR
SPACELABS HEALTHCARE (WASHINGTON), INC
Qube Mini
Not in Commercial Distribution

  • 10841522100239 ()
91389

  • Multiple vital physiological parameter monitoring system, clinical

Spacelabs Healthcare - 10841522100222

Remote Display Controller
SPACELABS HEALTHCARE (WASHINGTON), INC
91388
In Commercial Distribution

  • 10841522100222 ()
N/A

  • Centralized patient monitor

qube mini - 10841522131462

QUBE MINI TRANSPORT MONITOR
SPACELABS HEALTHCARE (WASHINGTON), INC
Qube Mini
In Commercial Distribution

  • 10841522131462 ()
91389

  • Multiple vital physiological parameter monitoring system, clinical

Xhibit - 10841522131141

DISPLAY,21.5",CAPACITIVE TOUCH,BLACK,ANTI-GLARE
SPACELABS HEALTHCARE (WASHINGTON), INC
Exhibit Central
In Commercial Distribution

  • 10841522131141 ()

  • 21.5"
011-0262-00

  • Centralized patient monitor

Xhibit - 10841522129780

DISPLAY,21.5",CAPACITIVE TOUCH,BLACK, ANTI-GLARE
SPACELABS HEALTHCARE (WASHINGTON), INC
Exhibit Central
In Commercial Distribution

  • 10841522129780 ()
011-0241-02

  • Centralized patient monitor

UltraviewSL - 10841522108716

MONITOR, COMPACT, REFURBISHED
SPACELABS HEALTHCARE (WASHINGTON), INC
91369
In Commercial Distribution

  • 10841522108716 ()
R-91369

  • Multiple vital physiological parameter monitoring system, clinical

UltraviewSL - 10841522102981

KIT, DM3 UPDATE, V1.8
SPACELABS HEALTHCARE (WASHINGTON), INC
91330
Not in Commercial Distribution

  • 10841522102981 ()
V1.8

  • Multiple vital physiological parameter monitoring system, clinical

FETOLY-HEART - 03770033463000

Fetoly-Heart is a software that aims at helping sonographers, obstetricians, radiologists, maternal-fetal medicine specialists, and pediatric cardiologists (designated as healthcare professionals i.e. HCPs) to perform fetal ultrasound examinations of the fetal heart in real-time. Fetoly-Heart can be used by HCPs during fetal ultrasound examinations in the second and third trimesters (gestational age window: from 17 to 40 weeks). The software is intended to assist HCPs in the completeness assessment of the fetal heart ultrasound examination in accordance with national and international guidelines.
DIAGNOLY
1
In Commercial Distribution

  • 03770033463000 ()


  • Ultrasound imaging system application software

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
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