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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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Stethee Pro Mobile iOS Application - 09351356000048

Stethee Pro Mobile iOS Application is a component of the Stethee Pro Software System. The Stethee Pro Software System is intended for use with the Stethee Pro Electronic Stethoscope.
M3DICINE PTY LTD
2.0.X
In Commercial Distribution

  • 09351356000048 ()


  • Phonocardiograph
  • Stethoscope application software

Stethee Pro Mobile Android Application - 09351356000031

Stethee Pro Mobile Android Application is a component of the Stethee Pro Software System. The Stethee Pro Software System is intended for use with the Stethee Pro Electronic Stethoscope.
M3DICINE PTY LTD
2.0.X
In Commercial Distribution

  • 09351356000031 ()


  • Phonocardiograph
  • Stethoscope application software

BioSerenity-Link - 03615220003785

BioSerenity-Link is a mobile application capable of sharing phone connectivity, recording video and uploading it to the BioSerenity Cloud
BIOSERENITY MEDICAL DEVICES GROUP
5100-00021-UN
Not in Commercial Distribution

  • 03615220003785 ()


  • Camera application software
  • Medical networking interface unit

FractureDetect (FX) - 00852491008016

FractureDetect (FX) is a computer-assisted detection and diagnosis (CAD) software device to assist clinicians in detecting fractures during the review of radiographs of the musculoskeletal system. FX is indicated for adults only.
Imagen Technologies, Inc.
1.0.0
In Commercial Distribution

  • 00852491008016 ()


  • X-ray image interpretive software

Sentinel - 10841522103452

Cardiology Information Management System
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
Not in Commercial Distribution

  • 10841522103452 ()
10.0.1

  • Cardiac stress exercise monitoring system

PathfinderSL - 10841522103131

SENTINEL 10 WORKSTATION (X1) + 4 WEB LICENSES
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
Not in Commercial Distribution

  • 10841522103131 ()
040-1713-00

  • Cardiology information system application software

SENTINEL - 10841522103124

SENTINEL 10 WORKSTATION (X10) + ABP LICENSE
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
Not in Commercial Distribution

  • 10841522103124 ()
040-1712-00

  • Cardiology information system application software

Sentinel - 10841522103117

SENTINEL 10 WORKSTATION (X5) + ABP LICENSE
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
Not in Commercial Distribution

  • 10841522103117 ()
040-1711-00

  • Cardiology information system application software

Sentinel - 10841522103100

SENTINEL 10 WORKSTATION (X2) + ABP LICENSE
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
Not in Commercial Distribution

  • 10841522103100 ()
040-1710-00

  • Cardiology information system application software

Sentinel - 10841522103094

SENTINEL 10 WORKSTATION (X1) + ABP LICENSE
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
Not in Commercial Distribution

  • 10841522103094 ()
040-1709-00

  • Cardiology information system application software
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