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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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MiniMed™ Mobile - 00763000416676

SFTWR MMT-6102 AHCL APP 1.3.3 IOS
MEDTRONIC MINIMED, INC.
MMT-6102
In Commercial Distribution

  • 00763000416676 ()


  • Self-care monitoring/reporting software

InPen Smart Insulin Delivery System - 00763000489953

SOFTWARE MMT-8060 INSULIN PEN IOS APP
MEDTRONIC MINIMED, INC.
MMT-8060
In Commercial Distribution

  • 00763000489953 ()


  • Empty self-injector, mechanical

MiniMed™ Mobile - 00763000827793

Sftwr MMT-6102 AHCL 2.1.1 App iOS
MEDTRONIC MINIMED, INC.
MMT-6102
In Commercial Distribution

  • 00763000827793 ()


  • Self-care monitoring/reporting software

MiniMed™ Mobile - 00763000867638

SFTWR MMT-6102 AHCL APP 2.2 IOS
MEDTRONIC MINIMED, INC.
MMT-6102
In Commercial Distribution

  • 00763000867638 ()


  • Self-care monitoring/reporting software

MiniMed™ Mobile - 00763000943264

SFTWR MMT-6102 AHCL APP 2.6 IOS
MEDTRONIC MINIMED, INC.
MMT-6102
In Commercial Distribution

  • 00763000943264 ()


  • Self-care monitoring/reporting software

MiniMed™ Mobile - 00763000910150

SFTWR MMT-6102 AHCL APP 2.5 IOS
MEDTRONIC MINIMED, INC.
MMT-6102
In Commercial Distribution

  • 00763000910150 ()


  • Self-care monitoring/reporting software

MiniMed™ Mobile - 00763000968175

SFTWR MMT-6102 AHCL APP 2.7 IOS
MEDTRONIC MINIMED, INC.
MMT-6102
In Commercial Distribution

  • 00763000968175 ()


  • Self-care monitoring/reporting software

Guardian™ Connect App - 00763000158392

SFTWR CSS7200 GRDN IOS APP V3.2.1
MEDTRONIC MINIMED, INC.
CSS7200
In Commercial Distribution

  • 00763000158392 ()


  • Patient health record information system application software

FreeStyle Libre 3 App - 00357599817008

FreeStyle Libre 3 iOS App US
ABBOTT DIABETES CARE INC
72077-01
In Commercial Distribution

  • 00357599817008 ()
72077-01

  • Percutaneous interstitial fluid glucose monitoring system, electrochemical

FreeStyle Libre 2 App - 00357599810009

FreeStyle Libre 2 App iOS US
ABBOTT DIABETES CARE INC
71926-01
In Commercial Distribution

  • 00357599810009 ()
71926-01

  • Percutaneous interstitial fluid glucose monitoring system, electrochemical

DreamMapper App iOS - 00606959051331

DreamMapper iOS NA Instance v 2.13
Respironics, Inc.
2.13
In Commercial Distribution

  • 00606959051331 ()
1101478

  • Self-care monitoring/reporting software

DreamMapper App iOS - 00606959049932

DreamMapper iOS NA Instance v 2.11
Respironics, Inc.
2.11
In Commercial Distribution

  • 00606959049932 ()
1101478

  • Self-care monitoring/reporting software

DreamMapper App iOS - 00606959049086

DreamMapper iOS NA Instance v 2.10
Respironics, Inc.
2.10
In Commercial Distribution

  • 00606959049086 ()
1101478

  • Self-care monitoring/reporting software

Clarius Ultrasound Scanner - 07540205000397

No Description
Clarius Mobile Health Corp
App - iOS
In Commercial Distribution

  • 07540205000397 ()
12-01-00003

  • Ultrasound imaging system application software
  • Radiological PACS software

DreamMapper - 00606959054288

DreamMapper App iOS, Asia-Pacific Instance, version 2.17
Respironics, Inc.
2.17
In Commercial Distribution

  • 00606959054288 ()
1127959

  • Self-care monitoring/reporting software

DreamMapper - 00606959054271

DreamMapper App iOS, EMEA Instance, version 2.17
Respironics, Inc.
2.17
In Commercial Distribution

  • 00606959054271 ()
1128264

  • Self-care monitoring/reporting software

Baha Smart App - 09321502078962

iOS version of the Baha Smart App
Cochlear Bone Anchored Solutions AB
V 1.2
In Commercial Distribution

  • 09321502078962 ()
P1646054

  • Audiometric/hearing device software

Sugar.IQ™ - 00763000086619

SFTWR MMT-8100 IOS WATSON APP V2.1 UDI
MEDTRONIC MINIMED, INC.
MMT-8100
In Commercial Distribution

  • 00763000086619 ()


  • Self-care monitoring/reporting software

Guardian™ Connect App - 00763000186333

SFTWR CSS7200 GRDN MBL APP IOS V3.2.3
MEDTRONIC MINIMED, INC.
CSS7200
In Commercial Distribution

  • 00763000186333 ()


  • Patient health record information system application software

Sugar.IQ™ - 00763000168643

SFTWR MMT-8100 IOS WATSON APP V3.0 UDI
MEDTRONIC MINIMED, INC.
MMT-8100
In Commercial Distribution

  • 00763000168643 ()


  • Self-care monitoring/reporting software
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