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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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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
DreamMapper Mobile Application Android (EMEA)
Respironics, Inc.
2.5
In Commercial Distribution

  • 00606959042025 ()
1128265

  • 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
reSET-O® Mobile Application running on Android. reSET-O is intended to increase retention of patients with opioid use disorder (OUD) in outpatient treatment by providing cognitive behavioral therapy, as an adjunct to outpatient treatment that includes transmucosal buprenorphine and contingency management, for patients 18 years or older who are currently under the supervision of a clinician. reSET-O is indicated as a prescription-only digital therapeutic.
PEAR THERAPEUTICS, INC.
1
In Commercial Distribution

  • 10851580008125 ()


  • Mental health/function therapeutic software, screen-viewed
reSET-O® Mobile Application running on iOS. reSET-O is intended to increase retention of patients with opioid use disorder (OUD) in outpatient treatment by providing cognitive behavioral therapy, as an adjunct to outpatient treatment that includes transmucosal buprenorphine and contingency management, for patients 18 years or older who are currently under the supervision of a clinician. reSET-O is indicated as a prescription-only digital therapeutic.
PEAR THERAPEUTICS, INC.
1
In Commercial Distribution

  • 10851580008118 ()


  • Mental health/function therapeutic software, screen-viewed
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
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