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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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EnSite™ - 05415067046680

X EP System Display Workstation
ST. JUDE MEDICAL, INC.
ENSITE-R-DWS-2.0.1
In Commercial Distribution

  • 05415067046680 ()
ENSITE-R-DWS-2.0.1

  • Cardiac mapping system

EnSite™ - 05415067046666

X EP System
ST. JUDE MEDICAL, INC.
ENSITE-SYSTEM-201
In Commercial Distribution

  • 05415067046666 ()
ENSITE-SYSTEM-201

  • Cardiac mapping system

EnSite™ - 05415067034755

X EP System Amplifier
ST. JUDE MEDICAL, INC.
ENSITE-AMP-02
In Commercial Distribution

  • 05415067034755 ()
ENSITE-AMP-02

  • Cardiac mapping system

EnSite™ - 05415067034748

X EP System Amplifier
ST. JUDE MEDICAL, INC.
ENSITE-R-AMP-02
In Commercial Distribution

  • 05415067034748 ()
ENSITE-R-AMP-02

  • Cardiac mapping system

TIMS System - 00850951007265

TIMS Streamer transmits any live medical modality video over networks - LAN, WAN, VPN, and Internet. Provides secure, encrypted and HIPPA Compliant information. Usage includes live training, mentoring, proctoring and monitoring. Functionality includes recording segments and entire procedures.
FORESIGHT IMAGING, LLC
TIMS Streamer 1B
Not in Commercial Distribution

  • 00850951007265 ()
072000-100

  • Medical image management system

TIMS System - 00850951007036

TIMS Streamer transmits any live medical modality video over networks - LAN, WAN, VPN, and Internet. Provides secure, encrypted and HIPPA Compliant information. Usage includes live training, mentoring, proctoring and monitoring. Functionality includes recording segments and entire procedures.
FORESIGHT IMAGING, LLC
TIMS Streamer 1A
Not in Commercial Distribution

  • 00850951007036 ()
072000-100

  • Medical image management system

Happy Health - 00850068747177

No Description
HAPPY HEALTH, INC.
Happy Ring HR1401GB
In Commercial Distribution

  • 00850068747177 ()


  • Multiple vital physiological parameter monitoring system, home-use

Happy Health - 00850068747160

No Description
HAPPY HEALTH, INC.
Happy Ring HR1301GB
In Commercial Distribution

  • 00850068747160 ()


  • Multiple vital physiological parameter monitoring system, home-use

Happy Health - 00850068747153

No Description
HAPPY HEALTH, INC.
Happy Ring HR1201GB
In Commercial Distribution

  • 00850068747153 ()


  • Multiple vital physiological parameter monitoring system, home-use

Happy Health - 00850068747146

No Description
HAPPY HEALTH, INC.
Happy Ring HR1101GB
In Commercial Distribution

  • 00850068747146 ()


  • Multiple vital physiological parameter monitoring system, home-use
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