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
No Description
NXSTAGE MEDICAL, INC.
NX1379
Not in Commercial Distribution

  • M535NX1225NX1379 ()


  • Medical equipment clinical data interfacing software
No Description
FOURNITURES HOSPITALIERES INDUSTRIE
267363
In Commercial Distribution

  • 03661489673634 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
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
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
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