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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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Sirona PC App
DATRIX LLC
Sirona
In Commercial Distribution

  • 00851074007194 ()
RX22773-003

  • Telemetric electrocardiographic ambulatory recorder
Sirona Android App
DATRIX LLC
Sirona
In Commercial Distribution

  • 00851074007170 ()
RX22711-003

  • Telemetric electrocardiographic ambulatory recorder
BEYOND app iOS
Widex A/S
BEYOND app
In Commercial Distribution

  • 05706069659689 ()
5 300 0003 001

  • Hearing aid enhanced audio device, telecommunication/multimedia
COM-DEX app Android
Widex A/S
COM-DEX APP
In Commercial Distribution

  • 05706069599985 ()
5 300 0001 001

  • Hearing aid enhanced audio device, telecommunication/multimedia
COM-DEX app iOS
Widex A/S
COM-DEX APP
In Commercial Distribution

  • 05706069599978 ()
5 300 0000 001

  • Hearing aid enhanced audio device, telecommunication/multimedia
MOTION INTELLIGENCE APP
DJO, LLC
13-4024
In Commercial Distribution

  • 00190446293613 ()

  • UNIV


  • Kinesiology ambulatory recorder
SmartView Connect App
MICROPORT CRM SRL
SW001U
In Commercial Distribution

  • 08031527019932 ()
SW001U

  • Cardiology information system application software
Support App (Palma)
Advanced Bionics, LLC
CI-6517
In Commercial Distribution

  • 00840094491007 ()


  • Audiometric/hearing device software
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
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
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
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
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
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
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
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
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
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
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
STATION,WIRELESS READY,PULLCORD,BLUE ACT,COM,CONN
Crest Healthcare Supply
116648
In Commercial Distribution

  • B4841166480 ()


  • Nurse call system
909 P37,Z4,2L,1LD,AUDIO & COM SWAP,STKR
CURBELL MEDICAL PRODUCTS, INC.
3001-990-353
In Commercial Distribution

  • 00840828100359 ()
178

  • Electrical mains power extension cable
MTO 3 WAY MANIFOLD KIT PARMA COM GEN
MEDLINE INDUSTRIES, INC.
601621410
In Commercial Distribution

  • 20193489071884 ()
  • 10193489071887 ()
601621410

  • Angiography kit
MTO LEFT HEART KIT SEVEN RIVERS COM HOSP
MEDLINE INDUSTRIES, INC.
65193662
In Commercial Distribution

  • 10193489063233 ()
65193662

  • Angiography kit
MTO LEFT HEART KIT PARMA COM GEN HOSP
MEDLINE INDUSTRIES, INC.
651621415
In Commercial Distribution

  • 10193489076363 ()
651621415

  • Angiography kit
MTO LEFT HEART W/DT BOULDER COM HOSP
MEDLINE INDUSTRIES, INC.
650305414
In Commercial Distribution

  • 10193489075151 ()
650305414

  • Angiography kit
50PSI PRST COM AIR GAS REG CGA346 MRI
OHIO MEDICAL, LLC
GR-346-DCXX-XXM
In Commercial Distribution

  • 00628101618247 ()
GR-346-DCXX-XXM

  • Non-fixed medical gas cylinder regulator
DEL SYS DCS-C4-18F-US COM 26/29/31 NP
MEDTRONIC COREVALVE LLC
DCS-C4-18F-US
Not in Commercial Distribution

  • 00643169565623 ()


  • Aortic transcatheter heart valve bioprosthesis, stent-like framework
MTO LEFT HEART KIT SAN ANGELO COM MED
MEDLINE INDUSTRIES, INC.
60010991
In Commercial Distribution

  • 20193489040439 ()
  • 10193489040432 ()
60010991

  • Angiography kit
Hose 1ea, Com cable 1ea (1 set box)
DAESUNG MAREF CO.,LTD.
1000860
In Commercial Distribution

  • 18809315679814 ()
  • 08809315679817 ()
  • 28809315679811 ()


  • Hand/wrist continuous passive motion exerciser
COM PLACEM INST DE, #40-30 TIN, DL HNDL
NORDENT MANUFACTURING INC
REPFI40T-30T
In Commercial Distribution

  • 00840018647244 ()


  • Margin finishing dental file/rasp, reusable
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