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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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UbiqVue Multiparameter - B353UB25501

2A Wearable Biosensor
Lifesignals, Inc.
UB2550
In Commercial Distribution

  • B353UB25502 ()
  • B353UB25501 ()
  • B353UB25503 ()


  • Wearable multiple physiological parameter recorder, single-use

UbiqVue Holter - B353UB22511

2AYe Wearable Biosensor
Lifesignals, Inc.
UB2251
In Commercial Distribution

  • B353UB22512 ()
  • B353UB22511 ()
  • B353UB22513 ()


  • Electrocardiographic ambulatory recorder

UbiqVue Multiparameter - B353UB15501

1AX Wearable Biosensor
Lifesignals, Inc.
UB1550
In Commercial Distribution

  • B353UB15501 ()
  • B353UB15502 ()
  • B353UB15503 ()


  • Wearable multiple physiological parameter recorder, single-use

MonitorMe - B353MM12501

Wearable Biosensor - ECG Remote Monitoring Biosensor Patch
Lifesignals, Inc.
MM1250
Not in Commercial Distribution

  • B353MM12501 ()
  • B353MM12502 ()
  • B353MM12503 ()


  • Electrocardiography telemetric monitoring system

LifeSignals - B353LP12501

Wearable Biosensor - ECG Remote Monitoring Biosensor Patch
Lifesignals, Inc.
LP1250
Not in Commercial Distribution

  • B353LP12502 ()
  • B353LP12501 ()
  • B353LP12503 ()


  • Electrocardiographic ambulatory recorder

LifeSignal - B353LP11101

Biosensor Patch - Electrocardiography Telemetric Monitoring Patch
Lifesignals, Inc.
LP1110
Not in Commercial Distribution

  • B353LP11103 ()
  • B353LP11102 ()
  • B353LP11101 ()


  • Electrocardiography telemetric monitoring system

ImagineMIC - B353IM11101

Biosensor Patch - Electrocardiography Telemetric Monitoring Patch
Lifesignals, Inc.
IM1110
Not in Commercial Distribution

  • B353IM11103 ()
  • B353IM11102 ()
  • B353IM11101 ()


  • Electrocardiography telemetric monitoring system

Cherish Serenity - B353CS124501

Biosensor Patch - Electrocardiography Telemetric Monitoring Patch
Lifesignals, Inc.
CS1245
Not in Commercial Distribution

  • B353CS124502 ()
  • B353CS124501 ()
  • B353CS124503 ()


  • Electrocardiography telemetric monitoring system

ImagineMed - B353IM12101

Biosensor Patch - Electrocardiography Telemetric Monitoring Patch
Lifesignals, Inc.
IM1210
Not in Commercial Distribution

  • B353IM12103 ()
  • B353IM12102 ()
  • B353IM12101 ()


  • Electrocardiography telemetric monitoring system

CORVITALS - B353CV12451

Biosensor Patch - Electrocardiography Telemetric Monitoring Patch
Lifesignals, Inc.
CV1245
Not in Commercial Distribution

  • B353CV12452 ()
  • B353CV12451 ()
  • B353CV12453 ()


  • Electrocardiography telemetric monitoring system
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