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 Application iOS
Respironics, Inc.
2.7
In Commercial Distribution

  • 00606959046740 ()
1101478

  • Self-care monitoring/reporting software
DreamMapper Application iOS
Respironics, Inc.
2.5
In Commercial Distribution

  • 00606959041943 ()
1101478

  • Self-care monitoring/reporting software
DreamMapper Application iOS
Respironics, Inc.
2.6
In Commercial Distribution

  • 00606959044340 ()
1101478

  • Self-care monitoring/reporting software
reSET-O® Mobile Application running on iOS. reSET-O is a prescription-only digital therapy intended to deliver cognitive behavioral therapy (CBT) to patients with opioid use disorder (OUD). The Demo Version provides demonstration access to various prescription versions of the reSET-O product and is not intended for patients.
PEAR THERAPEUTICS, INC.
1
In Commercial Distribution

  • 10851580008231 ()


  • Mental health/function therapeutic software, screen-viewed
reSET® Mobile Application running on iOS. reSET is a prescription-only digital therapy intended to deliver cognitive behavioral therapy (CBT) to patients with substance use disorder (SUD). The Demo Version provides demonstration access to various prescription versions of the reSET product and is not intended for patients.
PEAR THERAPEUTICS, INC.
1
In Commercial Distribution

  • 10851580008200 ()


  • Mental health/function therapeutic software, screen-viewed
No Description
OXOS Medical, Inc.
APP
In Commercial Distribution

  • 00860008892744 ()


  • Hand-held basic diagnostic x-ray system, digital
Reusable SpO2 Sensor/天荣/Finger clip/Adult/3.0M/LP6/HOSPITECNICA
Unimed Medical Supplies, Inc.
HT410-194D
In Commercial Distribution

  • 06945664822220 ()


  • Pulse oximeter probe, reusable
No Description
Great Lakes Neurotechnologies Inc.
700-0026
In Commercial Distribution

  • 00859584006102 ()
700-0026

  • Tremor transducer
Novidan Mobile Application - iOS
Novidan, Inc.
99-0011-02
In Commercial Distribution

  • 00850049194464 ()


  • Air-conduction hearing aid, receiver-in-canal
t:connect Mobile Application (iOS)
Tandem Diabetes Care, Inc.
1004128
In Commercial Distribution

  • 00850006613274 ()


  • Ambulatory insulin infusion pump software, data-display
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