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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 - 07613389402971

myPhonak 4.0 app
Sonova AG
088-0013-04
In Commercial Distribution

  • 07613389402971 ()
088-0013-04

  • Audiometric/hearing device software

Phonak Brand - 07613389402964

myPhonak 4.0 app
Sonova AG
088-0013-11
In Commercial Distribution

  • 07613389402964 ()
088-0013-11

  • Audiometric/hearing device software

Phonak Brand - 07613389402957

myPhonak 4.0 app
Sonova AG
088-0013-02
In Commercial Distribution

  • 07613389402957 ()
088-0013-02

  • Audiometric/hearing device software

Phonak Brand - 07613389402940

myPhonak 4.0 app
Sonova AG
088-0013-07
In Commercial Distribution

  • 07613389402940 ()
088-0013-07

  • Audiometric/hearing device software

Phonak Brand - 07613389402933

myPhonak 4.0 app
Sonova AG
088-0013-08
In Commercial Distribution

  • 07613389402933 ()
088-0013-08

  • Audiometric/hearing device software

Phonak Brand - 07613389402926

myPhonak 4.0 app
Sonova AG
088-0013-45
In Commercial Distribution

  • 07613389402926 ()
088-0013-45

  • Audiometric/hearing device software

Phonak Brand - 07613389402919

myPhonak 4.0 app
Sonova AG
088-0013-15
In Commercial Distribution

  • 07613389402919 ()
088-0013-15

  • Audiometric/hearing device software

Phonak Brand - 07613389402810

myPhonak 4.0 app
Sonova AG
088-0013
In Commercial Distribution

  • 07613389402810 ()
088-0013

  • Audiometric/hearing device software

Phonak Brand - 07613389399301

myPhonak 4.0 app
Sonova AG
088-0013-18
In Commercial Distribution

  • 07613389399301 ()
088-0013-18

  • Audiometric/hearing device software

Phonak Brand - 07613389399288

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

  • 07613389399288 ()
088-0013-24

  • Audiometric/hearing device software

UbiqVue - B353UA2251R1

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

  • B353UA2251R1 ()


  • Medical equipment clinical data interfacing software

RAW MATERIAL - 00190446293613

MOTION INTELLIGENCE APP
DJO, LLC
13-4024
In Commercial Distribution

  • 00190446293613 ()

  • UNIV


  • Kinesiology ambulatory recorder

Arial - 00840948100963

Arial Mobile App
Securitas Healthcare LLC
54600
In Commercial Distribution

  • 00840948100963 ()


  • Alarm application software

SmartView - 08031527019932

SmartView Connect App
MICROPORT CRM SRL
SW001U
In Commercial Distribution

  • 08031527019932 ()
SW001U

  • Cardiology information system application software

AB Remote - 00840094491007

Support App (Palma)
Advanced Bionics, LLC
CI-6517
In Commercial Distribution

  • 00840094491007 ()


  • 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

mySCS™ GO - 00191506020705

Therapy Controller App
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
SC-5275
In Commercial Distribution

  • 00191506020705 ()


  • Implantable spinal cord electrical stimulation system programmer

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 - 05714464146024

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

  • 05714464146024 ()


  • Hearing aid/implant system remote control

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 - 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

CARDINAL HEALTH - 10888439303599

ALLENTOWN LAP CHOLE APP
Cardinal Health 200, LLC
SLC11LLSL1
In Commercial Distribution

  • 50888439303597 ()
  • 10888439303599 ()
SLC11LLSL1

  • Laparoscopic surgical procedure kit, non-medicated, single-use
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