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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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GN Hearing - 05708296367672

SW,FSW AUDIGY 3.0,UP1
Gn Hearing A/S
23371100
In Commercial Distribution

  • 05708296367672 ()


  • Audiometric/hearing device software

GN Hearing - 05708296367641

DVD,FSW SF2.0,AV3,VA,UP1
Gn Hearing A/S
23370800
In Commercial Distribution

  • 05708296367641 ()


  • Audiometric/hearing device software

hearX - 00858177007465

Android Hearing Aid Programming App
INTRICON CORPORATION
Lexie
In Commercial Distribution

  • 00858177007465 ()
Lexie Android App

  • Audiometric/hearing device software

hearX - 00858177007458

IOS Hearing Aid Programming App
INTRICON CORPORATION
Lexie
In Commercial Distribution

  • 00858177007458 ()
Lexie IOS App

  • Audiometric/hearing device software

Hearing Help Express - 00858177007335

Android App
INTRICON CORPORATION
HHE Hearing
In Commercial Distribution

  • 00858177007335 ()
23354

  • Audiometric/hearing device software

hiHealth Innovations - 00858177007144

Android App
INTRICON CORPORATION
hiHearing
In Commercial Distribution

  • 00858177007144 ()
22958

  • Audiometric/hearing device software

Hearing Help Express - 00858177007113

iOS App
INTRICON CORPORATION
HHE Hearing
In Commercial Distribution

  • 00858177007113 ()
23150

  • Audiometric/hearing device software

hi Health Innovations - 00858177007069

IOS Remote Control App
INTRICON CORPORATION
Remote
In Commercial Distribution

  • 00858177007069 ()
22957

  • Audiometric/hearing device software

GN Hearing - 05708296351367

SW,FSW CS SMART FIT 1.18,UP1
Gn Hearing A/S
23351300
In Commercial Distribution

  • 05708296351367 ()


  • Audiometric/hearing device software

Widex - 05706069543247

Compass V5.7.2 CD-ROM
Widex A/S
COMPASS
In Commercial Distribution

  • 05706069543247 ()
9 512 0044 100

  • Audiometric/hearing device software

Coselgi - 05706069510010

Coselgi C-Tune 2.0
Widex A/S
C-Tune
In Commercial Distribution

  • 05706069510010 ()
9 513 0102 000

  • Audiometric/hearing device software

Oracle Health Patient Observer - 00853023006241

No Description
Cerner Corporation
CPO-I415
In Commercial Distribution

  • 00853023006241 ()
CFG_PATOBSRVR

  • Inpatient motion surveillance software

Oracle Health Patient Observer - 00853023006234

No Description
Cerner Corporation
CPO-SP6
In Commercial Distribution

  • 00853023006234 ()
CFG_PATOBSRVR

  • Inpatient motion surveillance software

Cerner FetaLink - 00853023006227

No Description
Cerner Corporation
FetaLink200
Not in Commercial Distribution

  • 00853023006227 ()


  • Obstetrical monitoring/analysis software

FetaLink+ - 00853023006210

No Description
Cerner Corporation
FetaLink+6
In Commercial Distribution

  • 00853023006210 ()


  • Obstetrical monitoring/analysis software

Oracle Health Patient Observer - 00853023006203

No Description
Cerner Corporation
CPO-SP4
In Commercial Distribution

  • 00853023006203 ()
CFG_PATOBSRVR

  • Inpatient motion surveillance software

Oracle Patient Observer - 00853023006197

No Description
Cerner Corporation
CPO-SP
In Commercial Distribution

  • 00853023006197 ()
CFG_PATOBSRVR

  • Inpatient motion surveillance software

FetaLink+ - 00853023006166

No Description
Cerner Corporation
FetaLink+5
In Commercial Distribution

  • 00853023006166 ()


  • Obstetrical monitoring/analysis software

FetaLink+® - 00853023006142

No Description
Cerner Corporation
FetaLink+4
In Commercial Distribution

  • 00853023006142 ()


  • Obstetrical monitoring/analysis software

FetaLink® - 00853023006081

No Description
Cerner Corporation
FetaLink2013
Not in Commercial Distribution

  • 00853023006081 ()


  • Obstetrical monitoring/analysis software

FetaLink+® - 00853023006050

No Description
Cerner Corporation
FetaLink+3
In Commercial Distribution

  • 00853023006050 ()


  • Obstetrical monitoring/analysis software

FetaLink® - 00853023006043

No Description
Cerner Corporation
FetaLink2014
Not in Commercial Distribution

  • 00853023006043 ()


  • Obstetrical monitoring/analysis software

Coselgi - 05706069685503

Coselgi C-tune II V2.5 DVD
Widex A/S
C-Tune II
In Commercial Distribution

  • 05706069685503 ()
9 513 0204 000

  • Audiometric/hearing device software

Widex - 05706069684469

COMPASS GPS V2.5 VA package
Widex A/S
COMPASS GPS
In Commercial Distribution

  • 05706069684469 ()
7 503 0123 001

  • Audiometric/hearing device software

Widex - 05706069684452

COMPASS GPS V2.5 package (Spanish)
Widex A/S
COMPASS GPS
In Commercial Distribution

  • 05706069684452 ()
7 503 0122 004

  • Audiometric/hearing device software

Widex - 05706069684445

COMPASS GPS V2.5 package (French)
Widex A/S
COMPASS GPS
In Commercial Distribution

  • 05706069684445 ()
7 503 0122 003

  • Audiometric/hearing device software

Widex - 05706069684438

COMPASS GPS V2.5 package (German)
Widex A/S
COMPASS GPS
In Commercial Distribution

  • 05706069684438 ()
7 503 0122 002

  • Audiometric/hearing device software

Widex - 05706069684421

COMPASS GPS V2.5 package (English)
Widex A/S
COMPASS GPS
In Commercial Distribution

  • 05706069684421 ()
7 503 0122 001

  • Audiometric/hearing device software

Widex - 05706069674729

Tinnitus app Android version 1.0
Widex A/S
Tinnitus app
In Commercial Distribution

  • 05706069674729 ()
5 300 0007 001

  • Tinnitus masking application software

Widex - 05706069674712

Tinnitus app iOS version 1.0
Widex A/S
Tinnitus app
In Commercial Distribution

  • 05706069674712 ()
5 300 0006 001

  • Tinnitus masking application software
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