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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 - 00606959054226

DreamMapper Mobile App Android, North America Instance, version 2.17
Respironics, Inc.
2.17
In Commercial Distribution

  • 00606959054226 ()
1101479

  • Self-care monitoring/reporting software

d-Nav® - 00860001044201

Hygieia d-Nav System Phone App - Apple iOS Operating System
HYGIEIA, INC.
V1m00b054i
In Commercial Distribution

  • 00860001044201 ()


  • Calculator, programmable

Stellar Medical - 00853162006416

1, Needle App 18ga x 20cm Brachytherapy Non-Waxed, St
STELLAR MEDICAL, LLC
NA-1820SQ-NWS
In Commercial Distribution

  • 00853162006416 ()


  • Radiological image marker, implantable
  • Brachytherapy injection needle

Philips Sonicare - 08710103988984

Software, Sonicare Power Tooth brush, Web download App Android
PHILIPS ORAL HEALTHCARE, LLC
HX9999/99
In Commercial Distribution

  • 08710103988984 ()


  • Basic electric toothbrush

Philips Sonicare - 08710103988977

Software, Sonicare Power Tooth brush, Web download App iOS
PHILIPS ORAL HEALTHCARE, LLC
HX9999/99
In Commercial Distribution

  • 08710103988977 ()


  • Basic electric toothbrush

DRIVEMEDICAL - 00822383577173

Pressure PreventionBlank Product Description: Balanced Aire APP Mattress Custom
Drive Devilbiss Healthcare
BA9600-CUSTOM
In Commercial Distribution

  • 00822383577173 ()


  • Alternating-pressure bed mattress overlay system
  • Alternating-pressure inflator
  • Alternating-pressure bed mattress overlay, reusable

Cora - 00810042481893

Tampons, Retail, App. Reg.25/Super 10/Super+ 10
Cora
02Tampons-322
In Commercial Distribution

  • 00850373007041 ()
  • 00810042481893 ()


  • Menstrual tampon, unscented

SpO2.COM® pediatric SpO2 disposable sensor - 10843997000489

No Description
MASIMO CORPORATION
1775
In Commercial Distribution

  • 10843997000489 ()
  • 00843997000482 ()


  • Pulse oximeter probe, single-use

SpO2.COM® Infant SpO2 disposable sensor - 10843997000472

No Description
MASIMO CORPORATION
1777
In Commercial Distribution

  • 10843997000472 ()
  • 00843997000475 ()


  • Pulse oximeter probe, single-use

SpO2.COM® adult SpO2 disposable sensor - 10843997000465

No Description
MASIMO CORPORATION
1774
In Commercial Distribution

  • 10843997000465 ()
  • 00843997000468 ()


  • Pulse oximeter probe, single-use

SpO2.COM® NRC-SL2 Spacelabs Replacement Cable - 00843997001434

No Description
MASIMO CORPORATION
2335
In Commercial Distribution

  • 00843997001434 ()


  • Electrical-only medical device connection cable, reusable

SpO2.COM® NRC-P8 Patient Cable, 3M - 00843997001427

No Description
MASIMO CORPORATION
1949
In Commercial Distribution

  • 00843997001427 ()


  • Electrical-only medical device connection cable, reusable

SpO2.COM® NRC-SL Spacelabs Replacement Cable - 00843997001410

No Description
MASIMO CORPORATION
1900
In Commercial Distribution

  • 00843997001410 ()


  • Electrical-only medical device connection cable, reusable

Biomeme GoDx App for US - 00810096640130

App for controlling Biomeme Frankin three9 thermocycler when used with the Biomeme Real-Time RT-PCR SARS-CoV-2 Test
Biomeme, Inc.
2.3.5
In Commercial Distribution

  • 00810096640130 ()


  • SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)

Dexcom Stelo iOS Watch App - 00386270004659

No Description
Dexcom, Inc.
SW14131
In Commercial Distribution

  • 00386270004659 ()


  • Percutaneous interstitial-fluid glucose monitoring system, electrochemical

Dexcom Stelo Android Mobile App - 00386270004642

No Description
Dexcom, Inc.
SW14117
In Commercial Distribution

  • 00386270004642 ()


  • Percutaneous interstitial-fluid glucose monitoring system, electrochemical

Dexcom Stelo iOS Mobile App - 00386270004635

No Description
Dexcom, Inc.
SW14116
In Commercial Distribution

  • 00386270004635 ()


  • Percutaneous interstitial-fluid glucose monitoring system, electrochemical

DreamMapper Mobile App Android (EMEA) - 00606959042025

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

  • 00606959042025 ()
1128265

  • Self-care monitoring/reporting software

reSET-O® Mobile App, Android - 10851580008125

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 App, iOS - 10851580008118

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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