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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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No Description
JERON ELECTRONIC SYSTEMS, INC.
Provider 700
In Commercial Distribution

  • 00860002736037 ()
Provider 700

  • Nurse call system
No Description
JERON ELECTRONIC SYSTEMS, INC.
Provider 790
In Commercial Distribution

  • 00860002736020 ()
Provider 790

  • Nurse call system
No Description
JERON ELECTRONIC SYSTEMS, INC.
Provider 680
In Commercial Distribution

  • 00860002736013 ()
Provider 680

  • Nurse call system
Rejoyn (also known as CT-152) is a digital therapeutic smartphone application (app) for the treatment of Major Depressive Disorder (MDD) symptoms. Rejoyn is a prescription smartphone app-based digital therapeutic administered to a user via the user’s smartphone device (running Apple iPhone operating system [iOS®] or Android™ operating system [OS]), which delivers a proprietary interactive cognitive emotional and behavioral therapeutic intervention. The core components of Rejoyn are the Emotional Faces Memory Task (EFMT) exercises, brief cognitive behavioral therapy (CBT)-based lessons to learn and apply key therapeutic skills, and short message service (SMS) text messaging to reinforce CBT-based lesson content and to encourage engagement with the app. It is intended for the treatment of MDD symptoms as an adjunct to clinician-managed outpatient care for adult patients with MDD aged 22 years and older. It is intended to reduce MDD symptoms. Rejoyn is designed for use as an adjunct to clinician-managed outpatient care over a period of 6 weeks for the treatment of MDD symptoms, followed by a 4-week extension period where CBT-based lesson content will be accessible but no new therapeutic content or EFMT exercises will be available. Rejoyn is not intended to be used as a stand-alone therapy or as a substitution for the patient’s clinician prescribed medications.
Otsuka Pharmaceutical Development & Commercialization, Inc.
CT-152
In Commercial Distribution

  • 00857335005121 ()
  • 57335-0005-12 ()
57335000512

  • Mental health/function therapeutic software, screen-viewed
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 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 1600 Programmer Cable is a non-sterile external component that is used to provide connectivity between the Model 2502 Clinician Programmer and the Model 2402 Mobile Charger.
Reshape Lifesciences Inc.
1600
Not in Commercial Distribution

  • 00857334004194 ()

  • Length: 60 Inch
1600

  • Vagus nerve electrical stimulation system programmer
Office Medic Software
VECTRACOR INC
6.0
In Commercial Distribution

  • 00857175006166 ()


  • Cardiopulmonary physiological parameter analysis software
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