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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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The sleep remote is an external device that is about the size of a cell phone and is used by the patient to activate the Inspire system before they go to sleep. The patient places the remote over the implanted IPG site, and uses push buttons on top of the programmer to: a.) turn the therapy ON or OFF, b.) temporarily suspend therapy, or c.) make adjustments to the stimulation strength (within limits set by the physician). The patient’s sleep remote also allows patients to check the status of the IPG battery. There are both visual and audio indicators that provide information on the IPG status (therapy ON/OFF, therapy paused, stimulation level and battery status). The Inspire sleep remote will only communicate with the Inspire IPG.
Inspire Medical Systems, Inc.
900-017-005
In Commercial Distribution

  • 00810098650175 ()
2580

  • Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
The sleep remote is an external device that is about the size of a cell phone and is used by the patient to activate the Inspire system before they go to sleep. The patient places the remote over the implanted IPG site, and uses push buttons on top of the programmer to: a.) turn the therapy ON or OFF, b.) temporarily suspend therapy, or c.) make adjustments to the stimulation strength (within limits set by the physician). The patient’s sleep remote also allows patients to check the status of the IPG battery. There are both visual and audio indicators that provide information on the IPG status (therapy ON/OFF, therapy paused, stimulation level and battery status). The Inspire sleep remote will only communicate with the Inspire IPG.
Inspire Medical Systems, Inc.
900-017-003
In Commercial Distribution

  • 00810098650083 ()
2580

  • Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
The sleep remote is an external device that is about the size of a cell phone and is used by the patient to activate the Inspire system before they go to sleep. The patient places the remote over the implanted IPG site, and uses push buttons on top of the programmer to: a.) turn the therapy ON or OFF, b.) temporarily suspend therapy, or c.) make adjustments to the stimulation strength (within limits set by the physician). The patient’s sleep remote also allows patients to check the status of the IPG battery. There are both visual and audio indicators that provide information on the IPG status (therapy ON/OFF, therapy paused, stimulation level and battery status). The Inspire sleep remote will only communicate with the Inspire IPG.
Inspire Medical Systems, Inc.
900-017-0051
In Commercial Distribution

  • 00810098650014 ()
2580

  • Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
VNS Therapy Kit
LIVANOVA USA, INC.
98142
In Commercial Distribution

  • 05425025750511 ()

  • Length: 2 Millimeter


  • Vascular graft tunneller
  • Vagus nerve electrical stimulation system lead
  • Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
Implantable Lead
LIVANOVA USA, INC.
304-30
In Commercial Distribution

  • 05425025750153 ()

  • Outer Diameter: 3.0 Millimeter


  • Vagus nerve electrical stimulation system lead
Implantable Lead
LIVANOVA USA, INC.
304-20
In Commercial Distribution

  • 05425025750139 ()

  • Outer Diameter: 2.0 Millimeter


  • Vagus nerve electrical stimulation system lead
Implantable Lead
LIVANOVA USA, INC.
303-30
In Commercial Distribution

  • 05425025750122 ()

  • Outer Diameter: 3.0 Millimeter


  • Vagus nerve electrical stimulation system lead
Implantable Lead
LIVANOVA USA, INC.
303-20
In Commercial Distribution

  • 05425025750115 ()

  • Outer Diameter: 2.0 Millimeter


  • Vagus nerve electrical stimulation system lead
Implantable Bipolar Lead
LIVANOVA USA, INC.
302-20
In Commercial Distribution

  • 05425025750092 ()

  • Outer Diameter: 2.0 Millimeter


  • Vagus nerve electrical stimulation system lead
Intera 3000 Hepatic Artery Infusion Pump and Operating Room Prep Kit
Intera Oncology Inc.
AP-03000H
In Commercial Distribution

  • 00850014110147 ()

  • Total Volume: 30 Milliliter
AP03000H

  • Implantable intrathecal infusion pump, nonprogrammable
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