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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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MUCheck® Independent Dose Calculation Software. MUCheck® Software. MUCheck® Software Suite. Oncology Data Systems, Inc.
Oncology Data Systems Inc
MUCheck®
In Commercial Distribution

  • 00860175002403 ()


  • Radiation therapy software
The Steth IO Spot is an acoustic device with an integrated microphone that collects biological sounds. Steth IO Spot attaches to the lightning port/USB-Type C (Universal Serial Bus Type C) port of the smartphone and can be utilized to auscultate patients during physical examination. The sound is then analyzed by the Steth IO Spot software telemedicine application (app) installed on the smartphone. This analysis enables a healthcare provider to identify sounds and from targeted areas of interest that may be present. A web portal (i.e., the Steth IO Portal) may also be used to access recorded patient data and to hold telemedicine calls.
Steth IO
1.0
In Commercial Distribution

  • 00860135001958 ()


  • Electronic acoustic stethoscope
Steth IO - The Smartphone Stethoscope for iPhone X
Steth IO
iPhone X
In Commercial Distribution

  • 00860135001934 ()


  • Electronic acoustic stethoscope
Steth IO - The Smartphone Stethoscope for iPhone 7+ or 8+
Steth IO
iPhone 7+/8+
In Commercial Distribution

  • 00860135001927 ()


  • Electronic acoustic stethoscope
Steth IO - The Smartphone Stethoscope for iPhone 7 or 8
Steth IO
iPhone 7/8
In Commercial Distribution

  • 00860135001910 ()


  • Electronic acoustic stethoscope
Steth IO - The Smartphone Stethoscope for iPhone 6
Steth IO
iPhone 6
In Commercial Distribution

  • 00860135001903 ()


  • Electronic acoustic stethoscope
No Description
WORK INCORPORATED
2049
Not in Commercial Distribution

  • 00860110000303 ()


  • Enteral feeding bag/bottle
No Description
GLYTEC, LLC
None
In Commercial Distribution

  • 00860057000305 ()


  • Infusion pump medication-dosage application software
No Description
Color Diagnostics, LLC
1.0
In Commercial Distribution

  • 00860014139307 ()


  • Specimen stabilization reagent IVD
  • Oral/respiratory tract specimen container IVD, additive/medium
No Description
LARONIX PTY LTD
1.0
In Commercial Distribution

  • 00860013939021 ()


  • Transcervical artificial larynx
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