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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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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

Guardian™ Connect App - 00763000381103

SFTWR CSS7200 GRDN MBL IOS V 4.1.0
MEDTRONIC MINIMED, INC.
CSS7200
In Commercial Distribution

  • 00763000381103 ()


  • Patient health record information system application software

Nucleus® Smart App - 09321502065764

Hearing Implant Software for iOS Devices
COCHLEAR LIMITED
P1861019
In Commercial Distribution

  • 09321502065764 ()
P2006651

  • Audiometric/hearing device software

Nucleus® Smart App - 09321502065757

Hearing Implant Software for Android Devices
COCHLEAR LIMITED
P1860864
In Commercial Distribution

  • 09321502065757 ()
P2006652

  • Audiometric/hearing device software

Eversense Mobile App Android - 00817491023537

Eversense CGM Mobile Application (Android) is a software application that runs on a mobile device (e.g., smart phone or tablet) and displays glucose data, trend information, and alerts.
SENSEONICS, INCORPORATED
FG-5502-02-300
In Commercial Distribution

  • 00817491023537 ()
FG-5502-02-300

  • Implantable glucose monitoring system

Eversense Mobile App iOS - 00817491023520

Eversense Mobile Application (iOS) is a software application that runs on a mobile device (e.g., smartphone or tablet) and displays glucose data, trend information, and alerts.
SENSEONICS, INCORPORATED
FG-5501-02-300
In Commercial Distribution

  • 00817491023520 ()
FG-5501-02-300

  • Implantable glucose monitoring system

RNA - 10851290002444

CC527 Multi-Level Carton
Rna Medical Division
CC527 Multi-Level
In Commercial Distribution

  • 10851290002444 ()
CC 527

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

RNA - 10851290002437

CC527 Level 3 carton
Rna Medical Division
CC527 Level 3
In Commercial Distribution

  • 10851290002437 ()
CC 527-3

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

RNA - 10851290002420

CC527 Level 2 Carton
Rna Medical Division
CC527 Level 2
In Commercial Distribution

  • 10851290002420 ()
CC 527-2

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

RNA - 10851290002413

CC527 Level 1 Carton
Rna Medical Division
CC527 Level 1
In Commercial Distribution

  • 10851290002413 ()
CC 527-1

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
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