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reSET® Mobile Application running on Android. reSET is intended to provide cognitive behavioral therapy, as an adjunct to a contingency management system, for patients 18 years of age and older who are currently enrolled in outpatient treatment under the supervision of a clinician. reSET is indicated as a 12 week (90 days) prescription-only treatment for patients with substance use disorder (SUD), who are not currently on opioid replacement therapy, who do not abuse alcohol solely, or who do not abuse opioids as their primary substance of abuse. It is intended to:
- increase abstinence from a patient’s substances of abuse during treatment, and
- increase retention in the outpatient treatment program.
PEAR THERAPEUTICS, INC.
1
In Commercial Distribution
- 10851580008095 ()
- Mental health/function therapeutic software, screen-viewed
reSET® Mobile Application running on iOS. reSET is intended to provide cognitive behavioral therapy, as an adjunct to a contingency management system, for patients 18 years of age and older who are currently enrolled in outpatient treatment under the supervision of a clinician. reSET is indicated as a 12 week (90 days) prescription-only treatment for patients with substance use disorder (SUD), who are not currently on opioid replacement therapy, who do not abuse alcohol solely, or who do not abuse opioids as their primary substance of abuse. It is intended to:
- increase abstinence from a patient’s substances of abuse during treatment, and
- increase retention in the outpatient treatment program.
PEAR THERAPEUTICS, INC.
1
In Commercial Distribution
- 10851580008088 ()
- Mental health/function therapeutic software, screen-viewed
No Description
BIOTRONIK SE & Co. KG
493241
In Commercial Distribution
- 04035479188733 ()
493241
- Implantable electrical stimulation device management software
No Description
BIOTRONIK SE & Co. KG
487878
In Commercial Distribution
- 04035479185817 ()
487878
- Implantable electrical stimulation device management software
Eko mobile app for android international platforms for use with Eko medical devices.
Eko Devices, Inc.
com.ekodevices.android.intl
In Commercial Distribution
- 00850010298061 ()
- Medical equipment clinical data interfacing software
DreamMapper Android APAC Instance v 2.13
Respironics, Inc.
2.13
In Commercial Distribution
- 00606959051317 ()
1127960
- Self-care monitoring/reporting software
DreamMapper Android EU Instance v 2.13
Respironics, Inc.
2.13
In Commercial Distribution
- 00606959051300 ()
1128265
- Self-care monitoring/reporting software
DreamMapper Android NA Instance v 2.13
Respironics, Inc.
2.13
In Commercial Distribution
- 00606959051294 ()
1101479
- Self-care monitoring/reporting software
DreamMapper Android APAC Instance v 2.11
Respironics, Inc.
2.11
In Commercial Distribution
- 00606959049918 ()
1127960
- Self-care monitoring/reporting software
DreamMapper Android EU Instance v 2.11
Respironics, Inc.
2.11
In Commercial Distribution
- 00606959049901 ()
1128265
- Self-care monitoring/reporting software
DreamMapper Android NA Instance v 2.11
Respironics, Inc.
2.11
In Commercial Distribution
- 00606959049895 ()
1101479
- Self-care monitoring/reporting software
DreamMapper Android APAC Instance v 2.10
Respironics, Inc.
2.10
In Commercial Distribution
- 00606959049079 ()
1127960
- Self-care monitoring/reporting software
DreamMapper Android EU Instance v 2.10
Respironics, Inc.
2.10
In Commercial Distribution
- 00606959049062 ()
1128265
- Self-care monitoring/reporting software
DreamMapper Android NA Instance v 2.10
Respironics, Inc.
2.10
In Commercial Distribution
- 00606959049055 ()
1101479
- Self-care monitoring/reporting software
No Description
Infinitus Medical Technologies LLC
FPLS-3000
In Commercial Distribution
- 00860003986806 ()
FPLS-3000
- Operating table patient positioning set, single-use
No Description
FOURNITURES HOSPITALIERES INDUSTRIE
267363
In Commercial Distribution
- 03661489673634 ()
- Orthopaedic prosthesis implantation positioning instrument, reusable
No Description
NXSTAGE MEDICAL, INC.
NX1379
Not in Commercial Distribution
- M535NX1225NX1379 ()
- Medical equipment clinical data interfacing software
Eversense CGM Mobile Application (android) is a software application that runs on a mobile device (e.g., smart phone or tablet) and displays glucose data, trend information, and alerts.
SENSEONICS, INCORPORATED
FG-5502-01-300
Not in Commercial Distribution
- 00817491023612 ()
FG-5502-01-300
- Implantable glucose monitoring system
Eversense CGM Mobile Application (iOS) is a software application that runs on a mobile device (e.g., smartphone or tablet) and displays glucose data, trend information, and alerts.
SENSEONICS, INCORPORATED
FG-5501-01-300
Not in Commercial Distribution
- 00817491023605 ()
FG-5501-01-300
- Implantable glucose monitoring system
The Eversense NOW Remote Monitoring App is intended for home use. The mobile app is intended to be a secondary device used to remotely view an Eversense CGM System user’s glucose information. The secondary display is not a replacement for either real time continuous glucose monitoring using the Eversense CGM System’s primary display, or for home blood glucose monitoring. The Eversense NOW Remote Monitoring App is not intended to be used to make treatment decisions or therapy adjustments.
SENSEONICS, INCORPORATED
FG-5902-01-300
In Commercial Distribution
- 00817491023490 ()
FG-5902-01-300
- Implantable glucose monitoring system