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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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Arial - 00840948100963

Arial Mobile App
Securitas Healthcare LLC
54600
In Commercial Distribution

  • 00840948100963 ()


  • Alarm application software

SJM™ - 05415067023810

Patient Controller App
ADVANCED NEUROMODULATION SYSTEMS, INC.
3871
Not in Commercial Distribution

  • 05415067023810 ()
3871

  • Multiple active implantable device programmer

SJM™ - 05415067023803

Clinician Programmer App
ADVANCED NEUROMODULATION SYSTEMS, INC.
3870
Not in Commercial Distribution

  • 05415067023803 ()
3870

  • Multiple active implantable device programmer

NA - 05415067034977

Patient Controller App
ST. JUDE MEDICAL, INC.
55500
In Commercial Distribution

  • 05415067034977 ()
55500

  • Multiple active implantable device programmer

NA - 05415067034960

Clinician Programmer App
ST. JUDE MEDICAL, INC.
55600
In Commercial Distribution

  • 05415067034960 ()
55600

  • Multiple active implantable device programmer

NeuroSphere™ - 05415067050311

Digital Health App
ADVANCED NEUROMODULATION SYSTEMS, INC.
3876
In Commercial Distribution

  • 05415067050311 ()
3876

  • Multiple active implantable device programmer

Nucleus - 09321502043236

Nucleus Smart App
COCHLEAR LIMITED
P1285539
In Commercial Distribution

  • 09321502043236 ()
P1285539

  • Audiometric/hearing device software

PMI Probasics® - 00841447104070

APP (Pads only)
COMPASS HEALTH BRANDS CORP.
SA901P
Not in Commercial Distribution

  • 00841447104070 ()
SA901P

  • Air-filled bed mattress overlay

DreamMapper App iOS - 00606959048560

DreamMapper App iOS
Respironics, Inc.
2.9
In Commercial Distribution

  • 00606959048560 ()
1101478

  • Self-care monitoring/reporting software

Onduo - 00860000249539

Onduo App Android
VERILY LIFE SCIENCES LLC
SW0004
In Commercial Distribution

  • 00860000249539 ()


  • Self-care monitoring/reporting software

Onduo - 00860000249522

Onduo App iOS
VERILY LIFE SCIENCES LLC
SW0003
In Commercial Distribution

  • 00860000249522 ()


  • Self-care monitoring/reporting software

Viewfinder remote app - 00690103215847

Viewfinder remote app
Edwards Lifesciences LLC
VFREM
In Commercial Distribution

  • 00690103215847 ()
VFREM

  • Bedside monitor remote-viewing software, physiological parameter
  • General-purpose multi-parameter bedside monitor

GN Hearing - 05708296196746

APP,GN SMARTAPP
Gn Hearing A/S
21607300
In Commercial Distribution

  • 05708296196746 ()


  • Hearing aid/implant system remote control

CONNEXX - 05714880187229

APP CONNEXX FIT2GO
Ws Audiology Usa, Inc.
Connexx Fit2Go
In Commercial Distribution

  • 05714880187229 ()
21023158

  • Audiometric/hearing device software

hear.com - 05714880113228

APP HEAR.COM HORIZON
Ws Audiology Usa, Inc.
hear.com horizon
In Commercial Distribution

  • 05714880113228 ()
10996569

  • Hearing aid/implant system remote control

Broomwell - 00851074007293

Sirona PC App
DATRIX LLC
Sirona
In Commercial Distribution

  • 00851074007293 ()
RX22773-004

  • Telemetric electrocardiographic ambulatory recorder

AMI - 00851074007255

Sirona PC App
DATRIX LLC
Sirona
In Commercial Distribution

  • 00851074007255 ()
RX22773-002

  • Telemetric electrocardiographic ambulatory recorder

CardioLabs - 00851074007248

Sirona PC App
DATRIX LLC
Sirona
In Commercial Distribution

  • 00851074007248 ()
RX22773-001

  • Telemetric electrocardiographic ambulatory recorder

AMI - 00851074007231

Sirona Android App
DATRIX LLC
Sirona
In Commercial Distribution

  • 00851074007231 ()
RX22711-002

  • Telemetric electrocardiographic ambulatory recorder

CardioLabs - 00851074007224

Sirona Android App
DATRIX LLC
Sirona
In Commercial Distribution

  • 00851074007224 ()
RX22711-001

  • Telemetric electrocardiographic ambulatory recorder
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