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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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InPen - 00763000974596

SW MMT-8061 INPEN 2.0 ANDROID APP US
MEDTRONIC MINIMED, INC.
MMT-8061
In Commercial Distribution

  • 00763000974596 ()


  • Empty self-injector, mechanical

InPen - 00763000974589

SW MMT-8060 INPEN 2.0 IOS APP US
MEDTRONIC MINIMED, INC.
MMT-8060
In Commercial Distribution

  • 00763000974589 ()


  • Empty self-injector, mechanical

CareLink SmartSync™ LINQ II™ Platform Application - 00763000891091

SW D00U027 SS LINQ II PLATFORM APP
MEDTRONIC, INC.
D00U027
In Commercial Distribution

  • 00763000891091 ()


  • Implantable cardiac device management application software

BabySat 3 Rx App - 00810099090079

Babysat System Application.
Owlet Baby Care, Inc.
2.23.0
In Commercial Distribution

  • 00810099090079 ()


  • Multiple vital physiological parameter monitoring system, home-use

myLUX™ Patient App - 00802526623110

For Insertable Cardiac Monitor
BOSTON SCIENTIFIC CORPORATION
622929-120
Not in Commercial Distribution

  • 00802526623110 ()
2929

  • Implantable cardiac device management application software

myLUX™ Patient App - 00802526623103

for Insertable Cardiac Monitor
BOSTON SCIENTIFIC CORPORATION
622939-120
Not in Commercial Distribution

  • 00802526623103 ()
2939

  • Implantable cardiac device management application software

myLUX™ Patient App - 00802526618215

for Insertable Cardiac Monitor
BOSTON SCIENTIFIC CORPORATION
2939
In Commercial Distribution

  • 00802526618215 ()
2939

  • Implantable cardiac device management application software

myLUX™ Patient App - 00802526618208

For Insertable Cardiac Monitor
BOSTON SCIENTIFIC CORPORATION
2929
In Commercial Distribution

  • 00802526618208 ()
2929

  • Implantable cardiac device management application software

myLUX™ patient app - 00802526607608

for Insertable Cardiac Monitor
BOSTON SCIENTIFIC CORPORATION
622925-100
In Commercial Distribution

  • 00802526607608 ()
622925-100

  • Implantable cardiac device management application software

eVu Senz App iOS - 07540191000623

No Description
Thought Technology Ltd.
SA4520
In Commercial Distribution

  • 07540191000623 ()


  • Psychophysiological biofeedback system
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