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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 - 00606959057715

DreamMapper App iOS (APAC)
Respironics, Inc.
DreamMapper App iOS, Asia-Pacific Instance - 2
In Commercial Distribution

  • 00606959057715 ()
1127959

  • Self-care monitoring/reporting software

DreamMapper - 00606959057708

DreamMapper App iOS (EMEA)
Respironics, Inc.
DreamMapper Mobile App iOS EMEA - 2
In Commercial Distribution

  • 00606959057708 ()
1128264

  • Self-care monitoring/reporting software

Nucleus - 09321502036788

Nucleus Smart App, (iOS)
COCHLEAR LIMITED
P832154
In Commercial Distribution

  • 09321502036788 ()
P832154

  • Audiometric/hearing device software

Baha - 09321502034180

Baha 5 Smart App
Cochlear Bone Anchored Solutions AB
P736025
Not in Commercial Distribution

  • 09321502034180 ()
P736025

  • Hearing aid/implant system remote control

Baha - 09321502034159

Baha 5 Smart App
Cochlear Bone Anchored Solutions AB
95448
Not in Commercial Distribution

  • 09321502034159 ()
95448

  • Hearing aid/implant system remote control

OvuSense - 05060508530114

OvuSense 2 App - Android
VIO HEALTHTECH LIMITED
M032 Android
In Commercial Distribution

  • 05060508530114 ()


  • Thermometric fertility analyser

OvuSense - 05060508530107

OvuSense 2 App - iOS
VIO HEALTHTECH LIMITED
M032 iOS
In Commercial Distribution

  • 05060508530107 ()


  • Thermometric fertility analyser

Seer Home - 09355751001235

Seer App: Epilepsy Management
SEER MEDICAL HOLDINGS LIMITED
Seer App: Epilepsy Management
Not in Commercial Distribution

  • 09355751001235 ()


  • Electroencephalograph

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

Medline - 10080196403998

PUMP,REPLACEMENT,APP,AIRONE
MEDLINE INDUSTRIES, INC.
MSCAOPUMP
In Commercial Distribution

  • 10080196403998 ()
MSCAOPUMP

  • Alternating-pressure inflator

Sirona - 00851074007149

Sirona B Android App
DATRIX LLC
RX22711
In Commercial Distribution

  • 00851074007149 ()


  • Telemetric electrocardiographic ambulatory recorder

Sirona - 00851074007132

Sirona B iOS App
DATRIX LLC
RX22674
In Commercial Distribution

  • 00851074007132 ()


  • Telemetric electrocardiographic ambulatory recorder

Sirona - 00851074007125

Sirona B PC App
DATRIX LLC
RX22673
In Commercial Distribution

  • 00851074007125 ()


  • Telemetric electrocardiographic ambulatory recorder

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 - 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® - 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® - 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 - 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

Oticon - 05707131328526

ON APP 1.2 ANDROID
Oticon A/S
176635
In Commercial Distribution

  • 05707131328526 ()


  • Hearing aid/implant system remote control

Oticon - 05707131328519

ON APP 1.2 IOS
Oticon A/S
176634
In Commercial Distribution

  • 05707131328519 ()


  • 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 - 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

Bernafon - 05714464127221

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

  • 05714464127221 ()


  • 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

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 - 05714464146017

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

  • 05714464146017 ()


  • 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

hi Health Innovations - 00858177007069

IOS Remote Control App
INTRICON CORPORATION
Remote
In Commercial Distribution

  • 00858177007069 ()
22957

  • Audiometric/hearing device software

Bionic Circle App, Android - 00850050080176

Bionic Circle App, Android
Beta Bionics, Inc.
BOM000083
In Commercial Distribution

  • 00850050080176 ()
BB5002

  • Ambulatory insulin infusion pump software, data-display

Bionic Circle App, iOS - 00850050080169

Bionic Circle App, iOS
Beta Bionics, Inc.
BOM000082
In Commercial Distribution

  • 00850050080169 ()
BB5001

  • Ambulatory insulin infusion pump software, data-display

Widex - 05706069702965

Widex ToneLink App Android
Widex A/S
ToneLink app
In Commercial Distribution

  • 05706069702965 ()
5 300 0017 001

  • Hearing aid enhanced audio device, telecommunication/multimedia

Widex - 05706069702958

Widex ToneLink App iOS
Widex A/S
ToneLink app
In Commercial Distribution

  • 05706069702958 ()
5 300 0016 001

  • Hearing aid enhanced audio device, telecommunication/multimedia

Widex - 05706069689112

Beyond App Android 1.2
Widex A/S
BEYOND app
In Commercial Distribution

  • 05706069689112 ()
5 300 0009 001

  • Hearing aid/implant system remote control

Widex - 05706069689105

Beyond App iOS 1.2
Widex A/S
BEYOND app
In Commercial Distribution

  • 05706069689105 ()
5 300 0008 001

  • Hearing aid/implant system remote control

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

Panacea - 00092237617946

DS Replacement APP Pump,
COMPASS HEALTH BRANDS CORP.
DS-NADJP
In Commercial Distribution

  • 30092237617947 ()
  • 00092237617946 ()


  • Alternating-pressure inflator

Roscoe Medical - 00092237602058

APP replacement pad, deluxe
COMPASS HEALTH BRANDS CORP.
APP-DLXP
In Commercial Distribution

  • 80092237602054 ()
  • 00092237602058 ()


  • Alternating-pressure bed mattress overlay, reusable
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