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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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Beltone - 05708296078790

USB,FSW,BT SOLUS MAX 1.0,US
Gn Hearing A/S
20477900
In Commercial Distribution

  • 05708296078790 ()


  • Audiometric/hearing device software

Beltone - 05708296078783

DVD,FSW,BT SOLUS MAX 1.0,US
Gn Hearing A/S
20477800
In Commercial Distribution

  • 05708296078783 ()


  • Audiometric/hearing device software

GN ReSound - 05708296078769

USB,FSW,RS SMART FIT 1.0,US
Gn Hearing A/S
20231110
In Commercial Distribution

  • 05708296078769 ()


  • Audiometric/hearing device software

GN ReSound - 05708296078752

DVD,FSW,RS SMART FIT 1.0,US
Gn Hearing A/S
20231410
In Commercial Distribution

  • 05708296078752 ()


  • Audiometric/hearing device software

GN ReSound - 05708296078745

DVD,FSW,AUDIGY 1.0
Gn Hearing A/S
20474200
In Commercial Distribution

  • 05708296078745 ()


  • Audiometric/hearing device software

GN ReSound - 05708296078462

USB,FSW,RS AVENTA 3.10#2,US
Gn Hearing A/S
20473500
In Commercial Distribution

  • 05708296078462 ()


  • Audiometric/hearing device software

GN ReSound - 05708296078455

DVD,FSW,RS AVENTA 3.10#2,US
Gn Hearing A/S
20473400
In Commercial Distribution

  • 05708296078455 ()


  • Audiometric/hearing device software

Beltone - 05708296077038

SW,FSW,BT,SOLUS PRO 1.11
Gn Hearing A/S
20450300
In Commercial Distribution

  • 05708296077038 ()


  • Audiometric/hearing device software

GN ReSound - 05708296077021

SW,FSW,RS AVENTA 3.11
Gn Hearing A/S
20450200
In Commercial Distribution

  • 05708296077021 ()


  • Audiometric/hearing device software

GN ReSound - 05708296077014

SW,FSW,AUDIGY 1.0
Gn Hearing A/S
20449000
In Commercial Distribution

  • 05708296077014 ()


  • Audiometric/hearing device software

GN ReSound - 05708296077007

USB,FSW,AUDIGY 1.0
Gn Hearing A/S
20448900
In Commercial Distribution

  • 05708296077007 ()


  • Audiometric/hearing device software

Beltone - 05708296076765

DVD,AIRLINK 2 UPDATE,BT
Gn Hearing A/S
20538700
In Commercial Distribution

  • 05708296076765 ()


  • 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

Widex - 05706069666113

COMPASS GPS V2.4 VA package (English)
Widex A/S
COMPASS GPS
In Commercial Distribution

  • 05706069666113 ()
7 503 0118 001

  • Audiometric/hearing device software

Coselgi - 05706069666083

Coselgi C-tune II V2.4 DVD
Widex A/S
C-Tune II
In Commercial Distribution

  • 05706069666083 ()
9 513 0202 000

  • Audiometric/hearing device software

Widex - 05706069665819

COMPASS GPS V2.4, USB plug
Widex A/S
COMPASS GPS
In Commercial Distribution

  • 05706069665819 ()
9 503 0855 000

  • Audiometric/hearing device software

Widex - 05706069665796

COMPASS GPS V2.4 package (Spanish)
Widex A/S
COMPASS GPS
In Commercial Distribution

  • 05706069665796 ()
7 503 0117 004

  • Audiometric/hearing device software

Widex - 05706069665789

COMPASS GPS V2.4 package (French)
Widex A/S
COMPASS GPS
In Commercial Distribution

  • 05706069665789 ()
7 503 0117 003

  • Audiometric/hearing device software

Widex - 05706069665772

COMPASS GPS V2.4 package (German)
Widex A/S
COMPASS GPS
In Commercial Distribution

  • 05706069665772 ()
7 503 0117 002

  • Audiometric/hearing device software

Widex - 05706069665765

COMPASS GPS V2.4 package (English)
Widex A/S
COMPASS GPS
In Commercial Distribution

  • 05706069665765 ()
7 503 0117 001

  • Audiometric/hearing device software

Widex - 05706069658675

COMPASS GPS V2.3, USB plug
Widex A/S
COMPASS GPS
In Commercial Distribution

  • 05706069658675 ()
9 503 0853 000

  • Audiometric/hearing device software

Coselgi - 05706069658125

C-Tune II
Widex A/S
C-Tune II
In Commercial Distribution

  • 05706069658125 ()
9 513 0200 000

  • Audiometric/hearing device software

Widex - 05706069656428

COMPASS GPS V2.3 package (Spanish)
Widex A/S
COMPASS GPS
In Commercial Distribution

  • 05706069656428 ()
7 503 0116 004

  • Audiometric/hearing device software

Widex - 05706069656411

COMPASS GPS V2.3 package (French)
Widex A/S
COMPASS GPS
In Commercial Distribution

  • 05706069656411 ()
7 503 0116 003

  • Audiometric/hearing device software

Widex - 05706069656404

COMPASS GPS V2.3 package (German)
Widex A/S
COMPASS GPS
In Commercial Distribution

  • 05706069656404 ()
7 503 0116 002

  • Audiometric/hearing device software

Widex - 05706069645934

COMPASS GPS V2.2 VA package
Widex A/S
COMPASS GPS
In Commercial Distribution

  • 05706069645934 ()
7 503 0114 001

  • Audiometric/hearing device software

Widex - 05706069645910

COMPASS GPS V2.2 package (French)
Widex A/S
COMPASS GPS
In Commercial Distribution

  • 05706069645910 ()
7 503 0113 003

  • Audiometric/hearing device software

Widex - 05706069645897

COMPASS GPS V2.2 package (English)
Widex A/S
COMPASS GPS
In Commercial Distribution

  • 05706069645897 ()
7 503 0113 001

  • Audiometric/hearing device software

Widex - 05706069633269

Compass V5.10.1
Widex A/S
COMPASS
In Commercial Distribution

  • 05706069633269 ()
9 512 0064 100

  • Audiometric/hearing device software

Widex - 05706069633221

Compass V5.9.2 CD-ROM
Widex A/S
COMPASS
In Commercial Distribution

  • 05706069633221 ()
9 512 0063 100

  • Audiometric/hearing device software
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