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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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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® - 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 - 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

Sirona - 00851074007125

Sirona B PC App
DATRIX LLC
RX22673
In Commercial Distribution

  • 00851074007125 ()


  • Telemetric electrocardiographic ambulatory recorder

DreamMapper App iOS (EMEA) - 00606959048577

DreamMapper App iOS (EMEA)
Respironics, Inc.
2.9
In Commercial Distribution

  • 00606959048577 ()
1128264

  • Self-care monitoring/reporting software

DreamMapper - 00606959047549

DreamMapper App iOS (APAC)
Respironics, Inc.
2.8
In Commercial Distribution

  • 00606959047549 ()
1127959

  • Self-care monitoring/reporting software

DreamMapper - 00606959046788

DreamMapper App iOS (APAC)
Respironics, Inc.
2.7
In Commercial Distribution

  • 00606959046788 ()
1127959

  • Self-care monitoring/reporting software

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

DreamMapper App iOS (APAC) - 00606959048584

DreamMapper App iOS (APAC)
Respironics, Inc.
2.9
In Commercial Distribution

  • 00606959048584 ()
1127959

  • Self-care monitoring/reporting software

DreamMapper - 00606959044111

DreamMapper App iOS (APAC)
Respironics, Inc.
2.6
In Commercial Distribution

  • 00606959044111 ()
1127959

  • Self-care monitoring/reporting software

Dexcom G7 iOS Watch App - 00386270005168

G7 iOS Watch App
Dexcom, Inc.
SW13355
In Commercial Distribution

  • 00386270005168 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical

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

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 - 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

Oticon - 05707131328519

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

  • 05707131328519 ()


  • Hearing aid/implant system remote control

Medline - 10080196403998

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

  • 10080196403998 ()
MSCAOPUMP

  • Alternating-pressure inflator

Connexx - 05714880283624

SOFTWARE APP CONNEXX 9.14
Ws Audiology Usa, Inc.
Connexx 9.14
In Commercial Distribution

  • 05714880283624 ()
21050774

  • Audiometric/hearing device software

Birdsong - 05714464168125

BIRDSONG APP 1.6.0 IOS
Sbo Hearing A/S
285029
In Commercial Distribution

  • 05714464168125 ()


  • Hearing aid wireless-fitting computer-aided set

Bernafon - 05714464168095

BERNAFON APP 1.6.0 IOS
Sbo Hearing A/S
285026
In Commercial Distribution

  • 05714464168095 ()


  • Hearing aid wireless-fitting computer-aided set

Bernafon - 05714464058938

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

  • 05714464058938 ()


  • 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 - 05714464133925

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

  • 05714464133925 ()


  • 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 - 05714464146024

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

  • 05714464146024 ()


  • 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

Sony - 05714880189308

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

  • 05714880189308 ()
21022296

  • Audiometric/hearing device software

LAMP WFL Discover App - 00816486021572

LAMP WFL Discover App
PRENTKE ROMICH COMPANY
LAMP WFL Discover
In Commercial Distribution

  • 00816486021572 ()
20426

  • Voice synthesizer/digitizer

PRC-Saltillo - 00816486021367

TC Discover App UDID
PRENTKE ROMICH COMPANY
Discover App
In Commercial Distribution

  • 00816486021367 ()
19285-9

  • Voice synthesizer/digitizer

HANSATON - 07613389127225

HANSATON Stream Remote App
Hansaton Akustik GmbH
088-5003
In Commercial Distribution

  • 07613389127225 ()
088-5003

  • Audiometric/hearing device software

UNITRON - 07613389075823

Unitron Remote Plus app
Unitron Hearing Division
088-5001
In Commercial Distribution

  • 07613389075823 ()
088-5001

  • Audiometric/hearing device software

Sonova - 07613389310962

Easy Line remote App
Sonova AG
088-0010
In Commercial Distribution

  • 07613389310962 ()
088-0010

  • Audiometric/hearing device software

Meridian Medical - 00815067042562

BARIATRIC APP PAD ONLY
COMPASS HEALTH BRANDS CORP.
1105
In Commercial Distribution

  • 30815067042563 ()
  • 00815067042562 ()


  • Alternating-pressure bed mattress overlay, reusable

Meridian Medical - 00815067040162

APP SYSTEM AIR ADJUSTABLE
COMPASS HEALTH BRANDS CORP.
1003
In Commercial Distribution

  • 30815067040163 ()
  • 00815067040162 ()


  • Alternating-pressure bed mattress overlay system

Unitron Brand - 07613389610925

Hearing Remote 5.0 app
Sonova AG
088-5017
In Commercial Distribution

  • 07613389610925 ()
088-5017

  • Audiometric/hearing device software

All-Day Clear 1.0 app - 07613389557930

All-Day Clear 1.0 app
Sonova AG
088-5015
In Commercial Distribution

  • 07613389557930 ()
088-5015

  • Audiometric/hearing device software

Roscoe Medical - 00092237602058

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

  • 80092237602054 ()
  • 00092237602058 ()


  • Alternating-pressure bed mattress overlay, reusable

Roscoe Medical - 00092237602027

APP Replacement pad, basic
COMPASS HEALTH BRANDS CORP.
APP-BPD
In Commercial Distribution

  • 80092237602023 ()
  • 00092237602027 ()


  • Alternating-pressure bed mattress overlay, reusable

Panacea - 00092237617946

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

  • 30092237617947 ()
  • 00092237617946 ()


  • Alternating-pressure inflator

CIONIC - G345620000030

CIONIC iOS Gateway App
Cionic, Inc.
10
In Commercial Distribution

  • G345620000030 ()
62000003

  • Gait-enhancement electrical stimulation system, external

VEA - 00190376470351

Vea - Mobile Alignment App
ALPHATEC SPINE, INC.
AIX21000
In Commercial Distribution

  • 00190376470351 ()


  • Orthopaedic/craniofacial implantation planning software

Perifit - 03770014642660

Kegel Exerciser with App
X6 INNOVATIONS
Green Perifit
In Commercial Distribution

  • 03770014642660 ()


  • Pelvic floor muscle exerciser

Perifit - 03770014642448

Kegel Exerciser with App
X6 INNOVATIONS
Pink Perifit
In Commercial Distribution

  • 03770014642448 ()


  • Pelvic floor muscle exerciser

Perifit Care+ - 03770014642196

Kegel Exerciser with App
X6 INNOVATIONS
Purple Perifit Care+
In Commercial Distribution

  • 03770014642196 ()


  • Pelvic floor muscle exerciser

Perifit Care - 03770014642165

Kegel Exerciser with App
X6 INNOVATIONS
Green Perifit Care
In Commercial Distribution

  • 03770014642165 ()


  • Pelvic floor muscle exerciser

Perifit Care - 03770014642134

Kegel Exerciser with App
X6 INNOVATIONS
Pink Perifit Care
In Commercial Distribution

  • 03770014642134 ()


  • Pelvic floor muscle exerciser

Biim iOS App, P2.0 - 07090045490327

Biim iOS App, P2.0
Biim Ultrasound AS
P001424
In Commercial Distribution

  • 07090045490327 ()
P001424

  • Hand-held ultrasound imaging system, body-surface
  • Extracorporeal ultrasound imaging transducer, hand-held

Biim iOS App, P1.3.2 - 07090045490303

Biim iOS App, P1.3.2
Biim Ultrasound AS
P001417
In Commercial Distribution

  • 07090045490303 ()
P001417

  • Extracorporeal ultrasound imaging transducer, hand-held
  • Hand-held ultrasound imaging system, body-surface

Biim iOS App, P1.3.1 - 07090045490228

Biim iOS App, P1.3.1
Biim Ultrasound AS
P001402
In Commercial Distribution

  • 07090045490228 ()
P001402

  • Extracorporeal ultrasound imaging transducer, hand-held
  • Hand-held ultrasound imaging system, body-surface
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