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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No Description
GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC
ABUS Workstation
In Commercial Distribution

  • 00840682100038 ()
H5014WS

  • Breast ultrasound imaging system
Invenia ABUS Scan Station-US Global
GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC
ABUS Scan Station
In Commercial Distribution

  • 00840682100021 ()


  • Breast ultrasound imaging system
No Description
GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC
ABUS System
Not in Commercial Distribution

  • 00840682100014 ()
H5014PM

  • Breast ultrasound imaging system
SEDASYS POWER SUPPLY UNIT
ETHICON ENDO-SURGERY, INC.
SEDPSU01
Not in Commercial Distribution

  • 10705036010210 ()
SEDPSU01

  • Intraprocedural physiologic-monitoring sedation system
SEDASYS CONTROL UNIT
ETHICON ENDO-SURGERY, INC.
SEDPRU01
Not in Commercial Distribution

  • 10705036010203 ()
SEDPRU01

  • Intraprocedural physiologic-monitoring sedation system
SEDASYS BEDSIDE MONITORING UNIT
ETHICON ENDO-SURGERY, INC.
SEDBMU01
Not in Commercial Distribution

  • 10705036010180 ()
SEDBMU01

  • Intraprocedural physiologic-monitoring sedation system
Display Workstation
ST. JUDE MEDICAL, INC.
PN-004711
In Commercial Distribution

  • 07640157990316 ()
PN-004711

  • Cardiac mapping system computer
Quartz Equipment
ST. JUDE MEDICAL, INC.
PN-004400
In Commercial Distribution

  • 07640157990194 ()
PN-004400

  • Cardiac mapping system computer
The Model 2740S&C Programmer Cable is responsible for transferring device data from the generator through the skin via short-range inductive radiofrequency (RF) telemetry. The programmer cable is powered by a wall outlet connection and wirelessly transfers data (via Bluetooth Low Energy) to the tablet.
Inspire Medical Systems, Inc.
900-026-001
In Commercial Distribution

  • 00810098650311 ()
2740S&C

  • Implantable sleep apnoea treatment system, respiration-sensing
The Model 2740S SleepSync Programmer Application is a standalone software that is downloaded and installed on a user-owned computer and paired by the user (clinician) with the Model 2740C Programmer Cable to non-invasively interrogate and program the Implantable Pulse Generator (IPG) of the Inspire Upper Airway Stimulation (UAS) System. The SleepSync Programmer Application provides the graphic user interface (GUI) for the SleepSync Programmer System (Model 2740S and Model 2740C) while the Programmer Cable provides the communications interface between the SleepSync Programmer Application and the IPG. The SleepSync Programmer Application has the capability to monitor respiratory waveforms, program stimulation modes, adjust stimulation parameter values, and store waveforms and settings.
Inspire Medical Systems, Inc.
900-029-001
In Commercial Distribution

  • 00810098650038 ()
2740S

  • Implantable sleep apnoea treatment system, respiration-sensing
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