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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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Infusion Safety Management Software
ICU MEDICAL, INC.
2.1
In Commercial Distribution

  • 00887709122802 ()
17003-01

  • Infusion pump medication-dosage application software
No Description
ICU MEDICAL, INC.
22-0117-0201-25
In Commercial Distribution

  • 15019517157888 ()


  • Infusion pump medication-dosage application software
No Description
ICU MEDICAL, INC.
22-0004-0204-25
In Commercial Distribution

  • 15019517157871 ()


  • 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
The Q21 is a 19 channel EEG amplifier with a low noise floor of 0.25 microvolts peak to peak from 0.1 to 10.0Hz, meaning that you can record brain wave data without worrying about noise contamination. On top of our low-noise design, the Q21 is a non-multiplexed, multi-channel readout amp, minimizing slew for the most accurate whole brain imaging, and giving you the exact readout of your EEG recordings, with no loss of data or smoothing.
NEUROFIELD, INC.
169
In Commercial Distribution

  • 00860410000379 ()


  • Multiple physiological signal amplifier
MultiView™ is a software application that provides various image processing and measurement tools to facilitate the interpretation of breast MRI images and enable diagnosis.
Hologic, Inc.
MultiView
In Commercial Distribution

  • 15420045504684 ()
SFW-03541

  • Laboratory instrument/analyser application software IVD
syngo Application Software VD1,syngo Application Software KIT,Registered Medical Devices,syngo Application Software GTIN 04056869012902
Siemens Healthcare GmbH
10849112
In Commercial Distribution

  • 04056869025919 ()


  • Basic diagnostic x-ray system application software
The Minuteful - kidney test is an in-vitro diagnostic, home-use urine analysis test system for the semi-quantitative measurement of albumin and creatinine in urine, as well as the presentation of their ratio, the albumin-creatinine ratio (ACR), with results that are intended to be used in conjunction with clinical evaluation as an aid in the assessment of kidney health.
HEALTHY.IO LTD
MNT KDN.US.GEN
In Commercial Distribution

  • 17290017272471 ()


  • Self-testing data clinician presentation application software IVD
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