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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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Tempo Insights™ is the healthcare provider-facing component of TempoSmart. Neither Tempo Insights nor TempoSmart is intended to replace the research, expertise, judgment, or treatment provided to patients by healthcare providers. TempoSmart™ is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. TempoSmart is intended to assist patients in managing their diabetes with guidance from their providers.
WELLDOC, INC.
v1.0
Not in Commercial Distribution

  • B553TEMPOINSIGHTS100 ()


  • Home pharmaceutical management support software
TouchChat HD w/ WordPower App
PRENTKE ROMICH COMPANY
TouchChat App
In Commercial Distribution

  • 00816486021015 ()
18626

  • Voice synthesizer/digitizer
Infusion Management System (IMS)
Fresenius Kabi AG
030-0027-05
Not in Commercial Distribution

  • 00811050530399 ()
IMS

  • Infusion pump medication-dosage application software
BASE
BECTON, DICKINSON AND COMPANY
516701
In Commercial Distribution

  • 60382905167012 ()
  • 50382905167015 ()
  • 00382905167010 ()
516701

  • Intravenous injection automated detection/documentation system processor/transmitter
GTIN for 17002-02, 1/EA
ICU MEDICAL FLEET SERVICES, LLC
17002-02
In Commercial Distribution

  • 00887709127241 ()


  • Medical equipment clinical data interfacing software
GTIN for 17005-02, 1/EA
ICU MEDICAL FLEET SERVICES, LLC
17005-02
In Commercial Distribution

  • 00887709127234 ()


  • Medical equipment clinical data interfacing software
GTIN for 17003-02, 1/EA
ICU MEDICAL FLEET SERVICES, LLC
17003-02
In Commercial Distribution

  • 00887709127227 ()


  • Infusion pump medication-dosage application software
MY TSF HOMECARE APP ANDROID
Smith & Nephew, Inc.
71075403
In Commercial Distribution

  • 00885556808016 ()
71075403

  • Wireless patient monitor/sensor reporting software, layperson-use
MY TSF HOMECARE APP iOS
Smith & Nephew, Inc.
71075402
In Commercial Distribution

  • 00885556746387 ()
71075402

  • Wireless patient monitor/sensor reporting software, layperson-use
SMART TSF.COM
Smith & Nephew, Inc.
71075401
In Commercial Distribution

  • 00885556746370 ()
71075401

  • External orthopaedic fixation frame calculation software
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