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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Medical Software
HILL-ROM, INC.
3.9
In Commercial Distribution

  • 00887761985186 ()


  • Bedside information system application software
User Software
INTUITIVE SURGICAL, INC.
610040
In Commercial Distribution

  • 00886874117538 ()


  • Image segmentation application software
DataTrak Software
Thermogenesis Corp.
150040
In Commercial Distribution

  • 00886368000841 ()


  • Blood centrifugation system containment kit
Medical Software
HILL-ROM, INC.
1.6
In Commercial Distribution

  • 00887761001572 ()


  • Obstetrics information system application software
Medical Software
HILL-ROM, INC.
3.6
In Commercial Distribution

  • 00887761001565 ()


  • Bedside information system application software
Medical Software
HILL-ROM, INC.
3.6
In Commercial Distribution

  • 00887761001558 ()


  • Bedside information system application software
Medical Software
HILL-ROM, INC.
4.0
In Commercial Distribution

  • 00887761995093 ()


  • Bedside information system application software
Medical Software
HILL-ROM, INC.
4.0
In Commercial Distribution

  • 00887761995086 ()


  • Bedside information system application software
Medical Software
HILL-ROM, INC.
4.1
In Commercial Distribution

  • 00887761979031 ()


  • Bedside information system application software
Medical Software
HILL-ROM, INC.
4.1
In Commercial Distribution

  • 00887761979024 ()


  • Bedside information system application software
Imaging software
GENDEX CORP.
3
In Commercial Distribution

  • EKAV101037680 ()
VIXWINPL

  • Radiology information system application software
TAGconnect Software
WELCH ALLYN, INC.
901099
In Commercial Distribution

  • 00732094296334 ()
TAGECG-SWF

  • Electrocardiographic ambulatory recorder
VISI-PITCH (SOFTWARE)
PENTAX OF AMERICA, INC.
3950C
In Commercial Distribution

  • 04961333236572 ()


  • Speech assistive training device
ORTHONEXT SOFTWARE
ORTHOFIX SRL
2.0
In Commercial Distribution

  • 18053340345675 ()
ORTHONEXTSW

  • Radiological PACS software
SedLine Module
MASIMO CORPORATION
4497
In Commercial Distribution

  • 00843997013895 ()
4497

  • Patient monitoring system module, electroencephalographic
SedLine Module
MASIMO CORPORATION
4432
In Commercial Distribution

  • 00843997013475 ()
4432

  • Patient monitoring system module, electroencephalographic
RD Sedline Patient Cable
MASIMO CORPORATION
4298
In Commercial Distribution

  • 00843997012485 ()


  • Patient monitoring system module, electroencephalographic
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
115-053713-00
In Commercial Distribution

  • 06936415905569 ()


  • General-purpose multi-parameter bedside monitor
Procleix NAT Manager Software is designed to collect data from Procleix assays, instruments, and pooling/lysis software, which allows operators to track individual donor blood samples and link them to the appropriate test results. The software collates the results of lysing, pooling and testing, assigns outcomes to individual samples according to a testing algorithm, and formats output files that can be sent to a Laboratory Information Management System (LIMS). Procleix NAT Manager Software also produces a variety of summary informational and analytical reports.
BIOMEDICAL DATA SOLUTIONS LIMITED
1.2
In Commercial Distribution

  • 05060496770011 ()


  • Blood bank information system application software
cobas Synergy Software is software which controls pre-analytic instruments used to manage tubes and pipette liquid sample material to form pools of samples, as a front-end to the cobas® 6800/8800 Systems. cobas Synergy Software is intended for use in plasma fractionation and whole blood testing laboratories. The software is intended to be used by personnel who are trained in its operation and are familiar with the associated assays and instruments.
BIOMEDICAL DATA SOLUTIONS LIMITED
1
In Commercial Distribution

  • 05060496770004 ()


  • Blood bank information system application software
No Description
Neurowave Systems Inc.
NS-901
In Commercial Distribution

  • B746NS90101 ()


  • Anaesthesia depth monitor
RD Sedline EEG Sensor Pediatric
MASIMO CORPORATION
4329
In Commercial Distribution

  • 00843997012805 ()
  • 10843997012802 ()
4329

  • Analytical scalp electrode, single-use
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
115-046969-00
In Commercial Distribution

  • 06944904096728 ()


  • Analytical scalp electrode, single-use
Quatro Sensor Kit, (25) 186-0106
Covidien LP
186-0106-PH
In Commercial Distribution

  • 90884521657515 ()
  • 30884521134502 ()


  • Anaesthesia depth monitor
BISX4 Module Refurbished, Software Version 1.15
Covidien LP
186-0224-SF-RFB
In Commercial Distribution

  • 10884521812376 ()


  • Anaesthesia depth monitor
BISX4 Module Refurbished, Software Version 1.15; For use with Nihon Kohden Monitors
Covidien LP
186-0224-NK-RFB
In Commercial Distribution

  • 10884521812369 ()


  • Anaesthesia depth monitor
Quatro Sensor Kit, (25) 186-0106
Covidien LP
186-0106-PH
In Commercial Distribution

  • 20884521134505 ()
  • 30884521134502 ()


  • Anaesthesia depth monitor
D/L, E500 CONTROL PANEL MODULE, US VERSION
Covidien LP
186-0199R-SF
In Commercial Distribution

  • 10884521713055 ()


  • Neurophysiologic monitoring system
BIS LoC 2 Channel, Refurbished, Software Version 1.13 For use with Philips Patient Monitors
Covidien LP
186-0199R-PH
In Commercial Distribution

  • 10884521702868 ()


  • Neurophysiologic monitoring system
BIS LoC 2 Channel Refurbished, Software Version 1.13 For use with Philips Patient Monitors
Covidien LP
186-0195-PHSPS
In Commercial Distribution

  • 10884521702851 ()


  • Neurophysiologic monitoring system
BIS LoC 4 Channel Refurbished, Software Version 1.15. For use with Philips Patient Monitors
Covidien LP
186-1030-PH
Not in Commercial Distribution

  • 10884521553170 ()


  • Neurophysiologic monitoring system
BISX4 Module
Covidien LP
186-0224-PHSPS
In Commercial Distribution

  • 10884521553163 ()


  • Anaesthesia depth monitor
BISX Module
Covidien LP
186-0195-uSF
In Commercial Distribution

  • 10884521533127 ()


  • Anaesthesia depth monitor
BISX Module
Covidien LP
186-0195-uPH
In Commercial Distribution

  • 10884521533110 ()


  • Anaesthesia depth monitor
BISX4 Module
Covidien LP
186-0224-USF
In Commercial Distribution

  • 10884521533103 ()


  • Anaesthesia depth monitor
BISX4 Module Software Version 1.15
Covidien LP
186-0224-SF
In Commercial Distribution

  • 10884521533097 ()


  • Anaesthesia depth monitor
BISX4 Module
Covidien LP
186-0224-SLM
In Commercial Distribution

  • 10884521533080 ()


  • Anaesthesia depth monitor
BISX4 Module Software Version 1.15; For use with Nihon Kohden Monitors
Covidien LP
186-0224-NK
In Commercial Distribution

  • 10884521533073 ()


  • Anaesthesia depth monitor
BISX4 Module
Covidien LP
186-0224-UPH
In Commercial Distribution

  • 10884521533066 ()


  • Anaesthesia depth monitor
BISX4 Module Software Version 1.15. For use with Philips Patient Monitors
Covidien LP
186-0224-PH
In Commercial Distribution

  • 10884521533059 ()


  • Anaesthesia depth monitor
BISX Module,Refurbished, Software Version 1.13
Covidien LP
186-0199-GE
In Commercial Distribution

  • 10884521186064 ()


  • Neurophysiologic monitoring system
OEM A2000 Simulator Demo,Refurbished
Covidien LP
186-0108-RFB
Not in Commercial Distribution

  • 10884521175501 ()


  • Anaesthesia depth monitor
Monitoring System
Covidien LP
DS186-1046
In Commercial Distribution

  • 10884521170278 ()


  • Anaesthesia depth monitor
Monitoring System
Covidien LP
DL186-1046
In Commercial Distribution

  • 10884521170261 ()


  • Anaesthesia depth monitor
BISX4 Module,Refurbished, Software Version 1.15,For use with BIS Monitors
Covidien LP
DL186-0224-AMS
In Commercial Distribution

  • 10884521170254 ()


  • Anaesthesia depth monitor
BISX4 Module,Refurbished, Software Version 1.15,For use with BIS Monitors
Covidien LP
DS186-0224-AMS
Not in Commercial Distribution

  • 10884521170247 ()


  • Anaesthesia depth monitor
BISX Module,Refurbished, Software Version 1.15,For use with BIS Monitors
Covidien LP
DS186-0195-AMS
In Commercial Distribution

  • 10884521170230 ()


  • Anaesthesia depth monitor
BISX Module,Refurbished, Software Version 1.15,For use with BIS Monitors
Covidien LP
DL186-0195-AMS
In Commercial Distribution

  • 10884521170223 ()


  • Anaesthesia depth monitor
Monitor with Pole Clamp,Refurbished
Covidien LP
DL186-1049
Not in Commercial Distribution

  • 10884521164031 ()


  • Anaesthesia depth monitor
Monitor,Refurbished
Covidien LP
DS186-1049
Not in Commercial Distribution

  • 10884521164024 ()


  • Anaesthesia depth monitor
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