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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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Baha Fitting Software 7 - 09321502075527

VA version of Baha Fitting Software 7
Cochlear Bone Anchored Solutions AB
V 7.0
In Commercial Distribution

  • 09321502075527 ()
P2121915

  • Hearing aid wireless-fitting computer-aided set

Task Force® Monitor Software - 09120073931009

Task Force Monitor Software inkl. Kunden-CD (multilingual)
CNSystems Medizintechnik AG
V2.3
Not in Commercial Distribution

  • 09120073931009 ()


  • Noninvasive haemodynamic monitoring system

Kosmos OTS iOS - 09353278000762

KOSMOS OTS iOS SOFTWARE PACKAGE [2.X]
ECHONOUS, INC.
P007944
In Commercial Distribution

  • 09353278000762 ()


  • Ultrasound imaging system application software

EchoNous Samsung S8 Tablet with Software - 09353278000663

EchoNous (Uscan) Samsung S8 Tablet with Software
ECHONOUS, INC.
P007635
In Commercial Distribution

  • 09353278000663 ()


  • Hand-held ultrasound imaging system, body-surface

EncoreAnywhere - 00606959042902

EncoreAnywhere Data Management Software (North American Instance)
Respironics, Inc.
2.32
In Commercial Distribution

  • 00606959042902 ()
1119756

  • Medical equipment clinical data interfacing software

EncorePro2 - 00606959053793

Encore Pro 2, Patient Management Software (DVD)
Respironics, Inc.
Encore Pro Patient Management Software - 2
In Commercial Distribution

  • 00606959053793 ()
1054785

  • Medical equipment clinical data interfacing software

EncoreAnywhere - 00606959047228

EncoreAnywhere Data Management Software (U.S. - North America)
Respironics, Inc.
2.35
In Commercial Distribution

  • 00606959047228 ()
1119756

  • Medical equipment clinical data interfacing software

Dexcom G5 Mobile Android App - 00386270000293

G5 Mobile Android App Stand Alone Software
Dexcom, Inc.
SW10940
In Commercial Distribution

  • 00386270000293 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical

Dexcom G5 Mobile IOS App - 00386270000002

G5 Mobile IOS App Stand Alone Software
Dexcom, Inc.
SW10611
In Commercial Distribution

  • 00386270000002 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical

CGMS® Solutions™ - 00613994675293

SOFTWARE MMT-7310 SOLNS EA CGMS V3.0C EN
MEDTRONIC MINIMED, INC.
MMT-7310
In Commercial Distribution

  • 00613994675293 ()


  • Home healthcare information system
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