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 Class Implantable

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Continuous Clinical Thermometer
ISANSYS LIFECARE LIMITED
Lifetemp Sensor - V2 - Large
In Commercial Distribution

  • 05060488680069 ()
  • 05060488680298 ()
Lifetemp Sensor - V2 - Large

  • Physiological measuring device wireless data capture/transfer unit
Continuous Clinical Thermometer
ISANSYS LIFECARE LIMITED
Lifetemp Sensor - V2 - Medium
In Commercial Distribution

  • 05060488680052 ()
  • 05060488680281 ()
Lifetemp Sensor - V2 - Medium

  • Physiological measuring device wireless data capture/transfer unit
Continuous Clinical Thermometer
ISANSYS LIFECARE LIMITED
Lifetemp Sensor - V2 - Large
In Commercial Distribution

  • 05060488680045 ()
  • 05060488680274 ()
Lifetemp Sensor - V2 - Large

  • Physiological measuring device wireless data capture/transfer unit
Continuous Clinical Thermometer
ISANSYS LIFECARE LIMITED
Lifetemp Sensor - Large
In Commercial Distribution

  • 05060488680038 ()
Lifetemp Sensor - Large

  • Physiological measuring device wireless data capture/transfer unit
Continuous Clinical Thermometer
ISANSYS LIFECARE LIMITED
Lifetemp Sensor - Medium
In Commercial Distribution

  • 05060488680021 ()
Lifetemp Sensor - Medium

  • Physiological measuring device wireless data capture/transfer unit
Continuous Clinical Thermometer
ISANSYS LIFECARE LIMITED
Lifetemp Sensor - Small
In Commercial Distribution

  • 05060488680014 ()
Lifetemp Sensor - Small

  • Physiological measuring device wireless data capture/transfer unit
Repackaged Service Kit SK009 Thermometer
Vivify Health, Inc.
SK009
In Commercial Distribution

  • 00850032055222 ()


  • Multiparameter physiologic analysis workstation
HOLTER CONNECT Relay Application is a software that is installed on a compatible commercially available platform (mobile or tablet) that manages secured wireless communication between the Biosensor and the HOLTER CONNECT Secure Server for transferring acquired ECG data by the Biosensor.
Lifesignals, Inc.
LA1252R
In Commercial Distribution

  • B353LA1252R1 ()


  • Physiological measuring device wireless data capture/transfer unit
Single Patient Relay Application
Lifesignals, Inc.
UA2550-R
In Commercial Distribution

  • B353UA2550R1 ()


  • Physiological measuring device wireless data capture/transfer unit
SM-X205 - 10.5 Screen - GSM Data entry & local display point tablet computer, 10.5 Screen
ISANSYS LIFECARE LIMITED
SM-X205 - 10.5 Screen - GSM
In Commercial Distribution

  • 05060488680311 ()
Gateway SM-X205 GSM

  • Physiological measuring device wireless data capture/transfer unit
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