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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BAROSTIM NEO Model 2102 Implantable Pulse Generator (US Commercial)
CVRX, INC.
2102
In Commercial Distribution

  • 00859144004432 ()
100054-202

  • Baroreceptor electrical stimulation system
Accessory Kit
CVRX, INC.
5500
In Commercial Distribution

  • 00859144004234 ()
100033-301

  • Baroreceptor electrical stimulation system
Magnet
CVRX, INC.
5000
In Commercial Distribution

  • 00859144004227 ()
100034-301

  • Baroreceptor electrical stimulation system
Neo Legacy Implantable Pulse Generator
CVRX, INC.
2100
In Commercial Distribution

  • 00859144004210 ()
100053-301

  • Baroreceptor electrical stimulation system
Carotid Sinus Lead Repair Kit
CVRX, INC.
5010
In Commercial Distribution

  • 00859144004203 ()
100056-301

  • Baroreceptor electrical stimulation system
Programmer System
CVRX, INC.
9010
In Commercial Distribution

  • 00859144004128 ()
100055-102

  • Baroreceptor electrical stimulation system
No Description
Heartware Inc.
1328
In Commercial Distribution

  • 00888707008723 ()
1328

  • Implantable ventricular circulatory assist system
No Description
Heartware Inc.
MCS1728ST
In Commercial Distribution

  • 00888707005395 ()
MCS1728ST

  • Implantable ventricular circulatory assist system
No Description
Heartware Inc.
1328
Not in Commercial Distribution

  • 00888707000451 ()
1328

  • Implantable ventricular circulatory assist system
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
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