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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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Phonak Brand - 07613389399288

myPhonak 4.0 app
Sonova AG
088-0013-24
In Commercial Distribution

  • 07613389399288 ()
088-0013-24

  • Audiometric/hearing device software

Nalu Medical, Inc. - 00812537030463

SCS Programming App
NALU MEDICAL, INC.
53001
In Commercial Distribution

  • 00812537030463 ()
53001

  • Implantable electrical stimulation device management software

UbiqVue - B353UA2251R1

Holter Mobile App
Lifesignals, Inc.
UA2251-R
In Commercial Distribution

  • B353UA2251R1 ()


  • Medical equipment clinical data interfacing software

Eloquence - 00816486021237

Eloquence iOS App
PRENTKE ROMICH COMPANY
Eloquence App
In Commercial Distribution

  • 00816486021237 ()
19683

  • Voice synthesizer/digitizer

PRC-Saltillo - 00816486021183

Dialogue AAC App
PRENTKE ROMICH COMPANY
Dialogue App
In Commercial Distribution

  • 00816486021183 ()
18312

  • Voice synthesizer/digitizer

Saltillo - 00816486021053

TouchChat HD App
PRENTKE ROMICH COMPANY
TouchChat App
In Commercial Distribution

  • 00816486021053 ()
18626-4

  • Voice synthesizer/digitizer

Saltillo - 00816486021022

Classic TouchChat App
PRENTKE ROMICH COMPANY
TouchChat App
In Commercial Distribution

  • 00816486021022 ()
18626-0

  • Voice synthesizer/digitizer

Dexcom G7 Android App - 00386270001870

G7 Android App
Dexcom, Inc.
SW12299
In Commercial Distribution

  • 00386270001870 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical

Dexcom G7 iOS App - 00386270001863

G7 iOS App
Dexcom, Inc.
SW12300
In Commercial Distribution

  • 00386270001863 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical

Remidio - 08906096520014

FOP NM-10 is indicated for screening, capture and storage of images of the eye and surrounding area, FOP NM 10 camera is been designed for true colour and monochrome imaging in visible spectrum of light and consists of an incoherent light source. Light from the device is shown into the patient eye & the camera of a smart phone is used to capture images of the eye.
REMIDIO INNOVATIVE SOLUTIONS PRIVATE LIMITED
001
In Commercial Distribution

  • 08906096520014 ()


  • Ophthalmic fundus camera
  • Smartphone camera ophthalmic imaging lens

Lilly Together - 00300021458553

Software as a medical device (SaMD) for some Lilly medicines which provides access to medication reminders and customer support services; Operates on Android devices (various manufacturers)
ELI LILLY AND COMPANY
MA9141 Android (Version 17)
In Commercial Distribution

  • 00300021458553 ()
MA9141001AM

  • Medication reminder application software
  • Patient subjective symptom recorder

Lilly Together - 00300021451554

Software as a medical device (SaMD) for some Lilly medicines which provides access to medication reminders and customer support services; Operates on Apple iOS devices
ELI LILLY AND COMPANY
MA9142 IOS (Version 17)
In Commercial Distribution

  • 00300021451554 ()
MA9142001AM

  • Medication reminder application software
  • Patient subjective symptom recorder

Lilly Together - 00300021286552

Software as a medical device (SaMD) for some Lilly medicines which provides access to medication reminders and customer support services; Operates on Apple iOS devices
ELI LILLY AND COMPANY
MA9162 IOS (Version 15)
In Commercial Distribution

  • 00300021286552 ()
MA9162001AM

  • Medication reminder application software
  • Patient subjective symptom recorder

Lilly Together - 00300021285555

Software as a medical device (SaMD) for some Lilly medicines which provides access to medication reminders and customer support services; Operates on Android devices (various manufacturers)
ELI LILLY AND COMPANY
MA9161 Android (Version 15)
In Commercial Distribution

  • 00300021285555 ()
MA9161001AM

  • Medication reminder application software
  • Patient subjective symptom recorder

Lilly Together - 00300021284558

Software as a medical device (SaMD) for some Lilly medicines which provides access to medication reminders and customer support services; Operates on Apple iOS devices
ELI LILLY AND COMPANY
MA9160 IOS (Version 14)
In Commercial Distribution

  • 00300021284558 ()
MA9160001AM

  • Medication reminder application software
  • Patient subjective symptom recorder

Lilly Together - 00300021283551

Software as a medical device (SaMD) for some Lilly medicines which provides access to medication reminders and customer support services; Operates on Android devices (various manufacturers)
ELI LILLY AND COMPANY
MA9159 Android (Version 14)
In Commercial Distribution

  • 00300021283551 ()
MA9159001AM

  • Medication reminder application software
  • Patient subjective symptom recorder

Lilly Together - 00300021177553

Software as a medical device (SaMD) for some Lilly medicines which provides access to medication reminders and customer support services; Operates on Apple iOS devices
ELI LILLY AND COMPANY
MA9158 IOS (Version 13)
In Commercial Distribution

  • 00300021177553 ()
MA9158001AM

  • Medication reminder application software
  • Patient subjective symptom recorder

Lilly Together - 00300021176556

Software as a medical device (SaMD) for some Lilly medicines which provides access to medication reminders and customer support services; Operates on Android devices (various manufacturers)
ELI LILLY AND COMPANY
MA9152 Android (Version 13)
In Commercial Distribution

  • 00300021176556 ()
MA9152001AM

  • Medication reminder application software
  • Patient subjective symptom recorder

Lilly Together - 00300021175559

Software as a medical device (SaMD) for some Lilly medicines which provides access to medication reminders and customer support services; Operates on Apple iOS devices
ELI LILLY AND COMPANY
MA9140 IOS (Version 12)
In Commercial Distribution

  • 00300021175559 ()
MA9140001AM

  • Medication reminder application software
  • Patient subjective symptom recorder

Lilly Together - 00300021174552

Software as a medical device (SaMD) for some Lilly medicines which provides access to medication reminders and customer support services; Operates on Android devices (various manufacturers)
ELI LILLY AND COMPANY
MA9135 ANDROID (Version 12)
In Commercial Distribution

  • 00300021174552 ()
MA9135001AM

  • Medication reminder application software
  • Patient subjective symptom recorder

Oticon - 05707131268600

STRPR 1.2 APP, DEMO BL STREAMER PRO 1.2 APP CL
Oticon A/S
139340
In Commercial Distribution

  • 05707131268600 ()


  • Hearing aid neck induction loop, wireless input

Oticon - 05707131268587

STRPR 1.2 APP, LINKED WH STREAMER PRO 1.2 APP CL
Oticon A/S
139350
In Commercial Distribution

  • 05707131268587 ()


  • Hearing aid neck induction loop, wireless input

Oticon - 05707131268518

STRPR 1.2 APP, LINKED BL STREAMER PRO 1.2 APP CL
Oticon A/S
138119
In Commercial Distribution

  • 05707131268518 ()


  • Hearing aid neck induction loop, wireless input

Bernafon - 05714464058938

Bernafon App 1.0.0 iOS
Sbo Hearing A/S
242482
In Commercial Distribution

  • 05714464058938 ()


  • Hearing aid/implant system remote control

Bernafon - 05714464058921

Bernafon App 1.0.0 Android
Sbo Hearing A/S
242481
In Commercial Distribution

  • 05714464058921 ()


  • Hearing aid/implant system remote control

hi Health Innovations - 00858177007069

IOS Remote Control App
INTRICON CORPORATION
Remote
In Commercial Distribution

  • 00858177007069 ()
22957

  • Audiometric/hearing device software

Bernafon - 05714464146017

BERNAFON APP 1.5.0 ANDROID
Sbo Hearing A/S
274910
In Commercial Distribution

  • 05714464146017 ()


  • Hearing aid/implant system remote control

Bernafon - 05714464139484

BERNAFON APP 1.4.0 ANDROID
Sbo Hearing A/S
270494
In Commercial Distribution

  • 05714464139484 ()


  • Hearing aid/implant system remote control

Bernafon - 05714464139439

BERNAFON APP 1.4.0 IOS
Sbo Hearing A/S
270489
In Commercial Distribution

  • 05714464139439 ()


  • Hearing aid/implant system remote control

Bernafon - 05714464146024

BERNAFON APP 1.5.0 IOS
Sbo Hearing A/S
274911
In Commercial Distribution

  • 05714464146024 ()


  • Hearing aid/implant system remote control

Bernafon - 05714464133925

BERNAFON APP 1.3.0 IOS
Sbo Hearing A/S
269352
In Commercial Distribution

  • 05714464133925 ()


  • Hearing aid/implant system remote control

Bernafon - 05714464133918

BERNAFON APP 1.3.0 ANDROID
Sbo Hearing A/S
269351
In Commercial Distribution

  • 05714464133918 ()


  • Hearing aid/implant system remote control

Bernafon - 05714464127221

BERNAFON APP 1.2.0 ANDROID
Sbo Hearing A/S
265713
In Commercial Distribution

  • 05714464127221 ()


  • Hearing aid/implant system remote control

Bernafon - 05714464127214

BERNAFON APP 1.2.0 IOS
Sbo Hearing A/S
265712
In Commercial Distribution

  • 05714464127214 ()


  • Hearing aid/implant system remote control

Bernafon - 05714464125166

BERNAFON APP 1.1.0 IOS
Sbo Hearing A/S
264782
In Commercial Distribution

  • 05714464125166 ()


  • Hearing aid/implant system remote control

Bernafon - 05714464125159

BERNAFON APP 1.1.0 ANDROID
Sbo Hearing A/S
264781
In Commercial Distribution

  • 05714464125159 ()


  • Hearing aid/implant system remote control

Sony - 05714880189308

Sony | Hearing Control App
Ws Audiology Usa, Inc.
Sony | Hearing Control
In Commercial Distribution

  • 05714880189308 ()
21022296

  • Audiometric/hearing device software

TempTraq® - 00851203006432

TempTraq Clinician Android App
BLUE SPARK TECHNOLOGIES, INC.
4.x.x
In Commercial Distribution

  • 00851203006432 ()


  • Wireless patient monitor/sensor reporting software, layperson-use

TempTraq® - 00851203006388

TempTraq Clinician Web App
BLUE SPARK TECHNOLOGIES, INC.
4.x.x
In Commercial Distribution

  • 00851203006388 ()


  • Wireless patient monitor/sensor reporting software, layperson-use

TempTraq® - 00851203006371

TempTraq Patient iOS App
BLUE SPARK TECHNOLOGIES, INC.
4.x.x
In Commercial Distribution

  • 00851203006371 ()


  • Wireless patient monitor/sensor reporting software, layperson-use

TempTraq® - 00851203006364

TempTraq Patient Android App
BLUE SPARK TECHNOLOGIES, INC.
4.x.x
In Commercial Distribution

  • 00851203006364 ()


  • Wireless patient monitor/sensor reporting software, layperson-use

TempTraq® - 00851203006173

TempTraq Clinician Web App
BLUE SPARK TECHNOLOGIES, INC.
TempTraq Clinician Web App
Not in Commercial Distribution

  • 00851203006173 ()


  • Wireless patient monitor/sensor reporting software, layperson-use

TempTraq® - 00851203006142

TempTraq Clinician iOS App
BLUE SPARK TECHNOLOGIES, INC.
TempTraq Clinician iOS App
Not in Commercial Distribution

  • 00851203006142 ()


  • Wireless patient monitor/sensor reporting software, layperson-use

TempTraq® - 00851203006135

TempTraq Patient iOS App
BLUE SPARK TECHNOLOGIES, INC.
TempTraq Patient iOS App
Not in Commercial Distribution

  • 00851203006135 ()


  • Wireless patient monitor/sensor reporting software, layperson-use

TempTraq® - 00851203006128

TempTraq Clinician Android App
BLUE SPARK TECHNOLOGIES, INC.
TempTraq Clinician Android App
Not in Commercial Distribution

  • 00851203006128 ()


  • Wireless patient monitor/sensor reporting software, layperson-use

TempTraq® - 00851203006111

TempTraq Patient Android App
BLUE SPARK TECHNOLOGIES, INC.
TempTraq Patient Android App
Not in Commercial Distribution

  • 00851203006111 ()


  • Wireless patient monitor/sensor reporting software, layperson-use

TempTraq - 00851203006043

TempTraq Consumer iOS App
BLUE SPARK TECHNOLOGIES, INC.
TempTraq Consumer iOS App
Not in Commercial Distribution

  • 00851203006043 ()


  • Wireless patient monitor/sensor reporting software, layperson-use

TempTraq - 00851203006036

TempTraq Consumer Android App
BLUE SPARK TECHNOLOGIES, INC.
TempTraq Consumer Android App
Not in Commercial Distribution

  • 00851203006036 ()


  • Wireless patient monitor/sensor reporting software, layperson-use

Widex - 05706069930320

Widex MOMENT App Android
Widex A/S
Moment app
In Commercial Distribution

  • 05706069930320 ()
5 300 0022 001

  • Hearing aid enhanced audio device, telecommunication/multimedia

Widex - 05706069930313

Widex MOMENT App iOS
Widex A/S
Moment app
In Commercial Distribution

  • 05706069930313 ()
5 300 0021 001

  • Hearing aid enhanced audio device, telecommunication/multimedia
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