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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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MODD1 Pump - 00850037806096

Box of one (1) MODD1 Pump, software version v1.X
Modular Medical, Inc.
MODD1 Insulin Delivery System
In Commercial Distribution

  • 00850037806102 ()
  • 00850037806096 ()
MTL-54

  • Ambulatory insulin infusion pump, electronic, non-software-dosing

EnSite™ - 05415067050021

X EP System TactiFlex Ablation Catheter, Sensor Enabled Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-TFM-3.0.2
In Commercial Distribution

  • 05415067050021 ()
ENSITE-TFM-3.0.2

  • Cardiac mapping system application software

EnSite™ - 05415067049711

X EP System TactiFlex Ablation Catheter, Sensor Enabled Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-TFM-3.1
In Commercial Distribution

  • 05415067049711 ()
ENSITE-TFM-3.1

  • Cardiac mapping system application software

EnSite™ - 05415067048356

X EP System EnSite VoXel Flex Mode Demo Software License
ST. JUDE MEDICAL, INC.
ENSITE-D-FLEX-01
In Commercial Distribution

  • 05415067048356 ()
ENSITE-D-FLEX-01

  • Cardiac mapping system application software

EnSite™ - 05415067046673

X EP System TactiFlex Ablation Catheter, Sensor Enabled Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-TFM-02
In Commercial Distribution

  • 05415067046673 ()
ENSITE-TFM-02

  • Cardiac mapping system application software

Care Orchestrator - 00606959055414

Care Orchestrator, Clinical data collection management information system application software
Respironics, Inc.
1.19
In Commercial Distribution

  • 00606959055414 ()
1126366

  • Medical equipment clinical data interfacing software

Care Orchestrator - 00606959054790

Care Orchestrator, Clinical data collection management information system application software
Respironics, Inc.
Care Orchestrator, Clinical data collection software - 1
In Commercial Distribution

  • 00606959054790 ()
1126366

  • Medical equipment clinical data interfacing software

Care Orchestrator - 00606959053922

Care Orchestrator, Clinical data collection management information system application software
Respironics, Inc.
1.17
In Commercial Distribution

  • 00606959053922 ()
1126366

  • Medical equipment clinical data interfacing software

Care Orchestrator - 00606959053533

Care Orchestrator, Clinical data collection management information system application software
Respironics, Inc.
1.16
In Commercial Distribution

  • 00606959053533 ()
1126366

  • Medical equipment clinical data interfacing software

Acitware - 00606959039872

Actiware Activity Analysis Software (for use with Actiwatch Activity Trackers)
Respironics, Inc.
Actiware Software Web Download - 6
In Commercial Distribution

  • 00606959039872 ()
1104776

  • Kinesiology ambulatory recorder
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