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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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inSIGHT Ultima - B019ULT1CIED0

inSIGHT Ultima® Air-Charged Manometry System
DIVERSATEK HEALTHCARE, INC.
ULT1-CIE-D
In Commercial Distribution

  • B019ULT1CIED0 ()
ULT1-CIE-D

  • Manometric gastrointestinal motility analysis system

inSIGHT - B019H12R4500300

inSIGHT Legacy Adaptor Cable
DIVERSATEK HEALTHCARE, INC.
H12R-4500-30
In Commercial Distribution

  • B019H12R4500300 ()
H12R-4500-30

  • Manometric gastrointestinal motility analysis system

Microlife - 06970388169450

No Description
MICROLIFE USA, INC.
Cuff-L-WBPO
In Commercial Distribution

  • 16970388169457 ()
  • 06970388169450 ()


  • Arrythmia-detection sphygmomanometer

Microlife - 06970388169436

No Description
MICROLIFE USA, INC.
CUFF-S-WBPO
In Commercial Distribution

  • 16970388169433 ()
  • 06970388169436 ()


  • Arrythmia-detection sphygmomanometer

Microlife - 06970388169290

No Description
MICROLIFE USA, INC.
Cuff-S-WBPH
In Commercial Distribution

  • 16970388169297 ()
  • 06970388169290 ()


  • Arrythmia-detection sphygmomanometer

Microlife - 06970388169191

No Description
MICROLIFE USA, INC.
CUFF-M-WBPH
In Commercial Distribution

  • 16970388169198 ()
  • 06970388169191 ()


  • Arrythmia-detection blood pressure ambulatory recorder

Digistat Smart Central - 17350097870032

Digistat Smart Central is an on-site integration solution which forwards medical device status and alarm information to the user via display devices provided by Ascom or third-party companies. Users receive, time-critical information from connected medical devices directly via their display devices as text, alarms or data. Digistat Smart Central allows users to be aware of their patients’ status and alarm conditions when they are away from the patient and associated medical devices.
ASCOM UMS SRL
SW000754
In Commercial Distribution

  • 17350097870032 ()


  • Alarm application software

Ascom - 17350088671273

No Description
Ascom (Sweden) AB
Unite Connect for Clinical Systems
In Commercial Distribution

  • 17350088671273 ()
SW000466

  • Alarm application software

Ascom - 17350088670016

No Description
Ascom (Sweden) AB
Cardiomax
In Commercial Distribution

  • 17350088670016 ()
SW000466

  • Alarm application software

Ascom - 17350088670009

No Description
Ascom (Sweden) AB
Mobile Monitoring Gateway (MMG)
In Commercial Distribution

  • 17350088670009 ()
SW000400

  • Alarm application software
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