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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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Fully Automatic Defibrillator
HEARTSINE TECHNOLOGIES LTD
SAM360P
In Commercial Distribution

  • M727SAM360P0 ()


  • Non-rechargeable public automated external defibrillator
Semi-Automatic External Defibrillator
HEARTSINE TECHNOLOGIES LTD
SAM 350P
In Commercial Distribution

  • M727SAM350P ()


  • Non-rechargeable public semi-automated external defibrillator
Contents:one 1 g tube n-BCA with self-piercing luer cap one 1 g vial Ta Powder one 10 mL vial Ethiodized Oil
Cerenovus, Inc.
631-500
In Commercial Distribution

  • 10886704029151 ()
631500

  • Neurovascular embolization plug
Contents:two 1 g tubes n-BCA with self-piercing luer cap one 1 g vial Ta Powder one 10 mL vial Ethiodized Oil
Cerenovus, Inc.
631-400
In Commercial Distribution

  • 10886704029144 ()
631400

  • Neurovascular embolization plug
The Model 2504 Clinician Programmer Kit consists of a Model 2502 Clinician Programmer, a Model 2402 Mobile Charger, a Model 2403-300 Clinician Transmit Coil, a Model 1620 AC Recharger, and a Model 1600 Programmer Cable that are packaged together.
Reshape Lifesciences Inc.
2504
Not in Commercial Distribution

  • 00857334004361 ()
2504

  • Vagus nerve electrical stimulation system programmer
The Model 2502 Clinician Programmer (CP) is a non-sterile external component that consists of a commercially available laptop computer configured with customized software. The CP connects to the Mobile Charger with a custom Programmer Cable. The CP enables the clinician to enter and modify therapy parameters and therapy schedule in the Rechargeable Neuroregulator. The graphical user interface of the CP allows the clinician to monitor system performance and patient compliance. The CP also provides access to the Instructions for Use manuals.
Reshape Lifesciences Inc.
2502
Not in Commercial Distribution

  • 00857334004354 ()
2502

  • Vagus nerve electrical stimulation system programmer
The Model 2404 Patient Kit consists of a Model 2402 Mobile Charger, a Model 2403-60 Patient Transmit Coil, a Model 1620 AC Recharger, and a Model 1660 Patient Transmit Coil Belt that are packaged together.
Reshape Lifesciences Inc.
2404
Not in Commercial Distribution

  • 00857334004347 ()
2404

  • Implant battery charger/performance analyser
The Model 2403-60 Transmit Coil is a non-sterile external component for use by the patient. The Transmit Coil is placed over the Rechargeable Neuroregulator (RNR) and attached to the Mobile Charger to provide a radio frequency link with the RNR for charging and communication.
Reshape Lifesciences Inc.
2403-60
Not in Commercial Distribution

  • 00857334004323 ()

  • Outer Diameter: 5 Inch
2403-60

  • Vagus nerve electrical stimulation system programmer
The Model 2403-300 Transmit Coil is a non-sterile external component that is placed within a standard sterile sleeve for use by a clinician in the operating room. The Transmit Coil is placed over the Rechargeable Neuroregulator (RNR) and attached to the Mobile Charger to provide a radio frequency link with the RNR for charging and communication.
Reshape Lifesciences Inc.
2403-300
Not in Commercial Distribution

  • 00857334004316 ()

  • Outer Diameter: 5 Inch
2403-300

  • Vagus nerve electrical stimulation system programmer
The Model 2402 Mobile Charger (MC) is a non-sterile external component that is powered by a rechargeable, lithium-ion battery. The MC charges the Rechargeable Neuroregulator (RNR) when connected to a Transmit Coil positioned over the RNR. The MC also provides communication between the Clinician Programmer and RNR to allow up and down loading of data, display battery charge levels, indicate proper positioning of the Transmit Coil, alert patient to fault conditions, and allow for inactivation of therapy and turning off the RNR if needed.
Reshape Lifesciences Inc.
2402
Not in Commercial Distribution

  • 00857334004309 ()

  • Width: 4.7 Inch
  • Height: 1.2 Inch
  • Length: 2 Inch
2402

  • Implant battery charger/performance analyser
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