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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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Aurix software for use with the Aurix system (DI: 00627908080011) The UDI for software is comprised of the following: GTIN + Additional Product Identification Assigned by the Manufacturer (ADDITIONAL ID) (which represents the software version) UDI Application Identifier for Additional Product Identification Assigned by the Manufacturer (ADDITIONAL ID) = 240
Vivosonic Inc
SWA002
Not in Commercial Distribution

  • 00627908090027 ()


  • Evoked-potential audiometer
Integrity software for use with the first generation Integrity V500 system (DI: 00627908010018) and the second generation of the Integrity V500 system (DI: 00627908020017). The UDI is comprised of the following: GTIN + Additional Product Identification Assigned by the Manufacturer (ADDITIONAL ID) (which represents the software version) UDI Application Identifier for Additional Product Identification Assigned by the Manufacturer (ADDITIONAL ID) = 240
Vivosonic Inc
SWA001
In Commercial Distribution

  • 00627908090010 ()


  • Otoacoustic emission system, battery-powered
  • Evoked-potential audiometer
The zensor software system is a web and PC based tool assisting clinicians in managing patients being monitored with Intelesens' medical devices. The web and PC components of the software can be configured to be used individually or together. The zensor+ software allows review of all physiological data that has been previously stored and downloaded from the monitoring device for later analysis by a clinician. The system is intended to be used to obtain physiological readings for use in routine check-ups. Any events or variations in physiological readings are not intended to be used to summon emergency care.
INTELESENS LIMITED
PN0811
In Commercial Distribution

  • 05060484630051 ()


  • Electrocardiography telemetric monitoring system
The zensor software system is a web and PC based tool assisting clinicians in managing patients being monitored with Intelesens' medical devices. The web and PC components of the software can be configured to be used individually or together. The zensoronline software has the option to receive wirelessly transmitted pre-defined event alerts from the Intelesens' monitoring device for review by healthcare practitioners and/or review all physiological data that has been previously stored and downloaded from the monitoring device for later analysis by a clinician. The system is intended to be used to obtain physiological readings for use in routine check-ups. Any events or variations in physiological readings are not intended to be used to summon emergency care.
INTELESENS LIMITED
PN0810
In Commercial Distribution

  • 05060484630044 ()


  • Electrocardiography telemetric monitoring system
The Pillar Variant Analysis Toolkit or PiVAT is an analytical software that comes on a preloaded workstation that is used to analyze sequencer data to generate applicable reports for the oncoReveal CDx
Pillar Biosciences, Inc.
SFW-2012 2.0
In Commercial Distribution

  • 00860001218275 ()
SFW-2012

  • Colorectal cancer genotyping IVD, kit, nucleic acid technique (NAT)
No Description
WAHTS HEARING LLC
0.X.X
In Commercial Distribution

  • 00860005068319 ()


  • Tone audiometer
Breathing therapy Biofeedback System
ACCELERATED CARE PLUS CORP
FlowSoftware
In Commercial Distribution

  • 00858703006313 ()


  • Bioelectrical signal analysis software
No Description
Norland at Swissray
4
In Commercial Distribution

  • 00866955000478 ()


  • Basic diagnostic x-ray system operation software
Software used for the interaction and programming of the Novi Device.
SCOTTCARE CORPORATION, THE
Novi Software
In Commercial Distribution

  • 00856298006237 ()
101633

  • Electrocardiographic long-term ambulatory recording analyser application software
Software used for interaction and programming of the TeleSenseRCM and TeleSense-E devices.
SCOTTCARE CORPORATION, THE
TeleSense Software
In Commercial Distribution

  • 00856298006213 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
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