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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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KIT,MATERNITY
Cardinal Health 200, LLC
MAT4397442
In Commercial Distribution

  • 50197106471607 ()
  • 10197106471609 ()
MAT4397442

  • Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use
The XVIVO Lung Disposables Kit contains a number of single-use, disposable sterile and non-sterile items intended to be used with the XVIVO Perfusion System (XPS™) for ex vivo reconditioning of donor lungs.
Xvivo Perfusion AB
19046
In Commercial Distribution

  • 07350069520401 ()
19046

  • Lung donor-organ preservation/evaluation system lung-interface set
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 2740 physician programmer is designed for use by a physician to non invasively interrogate and program the IPG. It is the only component in the Inspire system that contains software. This programmer consists of a tablet computer and a telemetry cable. The telemetry head communicates with the IPG through the skin via short range radio frequency (RF) telemetry, telemetry communication allows the physician to noninvasively interrogate and program the IPG. The telemetry head is powered by a wall outlet connection and wirelessly communicates (via wireless Bluetooth link) with the physician programmer tablet. The physician programmer has the capability to monitor respiratory waveforms, program stimulation modes, adjust stimulation parameter values, and store waveforms and settings.
Inspire Medical Systems, Inc.
900-004-117
In Commercial Distribution

  • 00810098650212 ()
2740

  • 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.
900-017-053
In Commercial Distribution

  • 00810098650199 ()
2580

  • Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
The Model 2740 physician programmer is designed for use by a physician to non invasively interrogate and program the IPG. It is the only component in the Inspire system that contains software. This programmer consists of a tablet computer and a telemetry cable. The telemetry head communicates with the IPG through the skin via short range radio frequency (RF) telemetry, telemetry communication allows the physician to noninvasively interrogate and program the IPG. The telemetry head is powered by a wall outlet connection and wirelessly communicates (via wireless Bluetooth link) with the physician programmer tablet. The physician programmer has the capability to monitor respiratory waveforms, program stimulation modes, adjust stimulation parameter values, and store waveforms and settings.
Inspire Medical Systems, Inc.
900-004-116
In Commercial Distribution

  • 00810098650151 ()
2740

  • Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
The Model 2740 physician programmer is designed for use by a physician to non invasively interrogate and program the IPG. It is the only component in the Inspire system that contains software. This programmer consists of a tablet computer and a telemetry cable. The telemetry head communicates with the IPG through the skin via short range radio frequency (RF) telemetry, telemetry communication allows the physician to noninvasively interrogate and program the IPG. The telemetry head is powered by a wall outlet connection and wirelessly communicates (via wireless Bluetooth link) with the physician programmer tablet. The physician programmer has the capability to monitor respiratory waveforms, program stimulation modes, adjust stimulation parameter values, and store waveforms and settings.
Inspire Medical Systems, Inc.
900-004-115
In Commercial Distribution

  • 00810098650007 ()
2740

  • Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
CYSTO PACK
Cardinal Health 200, LLC
SOT69CYMVA
In Commercial Distribution

  • 50197106743124 ()
  • 10197106743126 ()
SOT69CYMVA

  • Urological surgical procedure kit, non-medicated, single-use
System that detects fFN in cervicovaginal secretions.
Hologic, Inc.
TLiIQ System
In Commercial Distribution

  • 25420045500874 ()
01202

  • Fibronectin IVD, kit, enzyme immunohistochemistry
The Filshie Tubal Ligation System - Filshie Clips for permanent female sterilization by occlusion of the Fallopian tubes. Single pair of clips ONLY included with Sterishot applicator kits.
FEMCARE LIMITED
AVM-851SC
In Commercial Distribution

  • 05055515602268 ()
  • 25055515602262 ()
AVM-851SC

  • Fallopian tube clip/band
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