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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 Holter - B353UB22511

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

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


  • Electrocardiographic ambulatory recorder

UbiqVue Holter - B353UB12511

1AXe Wearable Biosensor
Lifesignals, Inc.
UB1251
In Commercial Distribution

  • B353UB12512 ()
  • B353UB12511 ()
  • B353UB12513 ()


  • Electrocardiographic ambulatory recorder

LifeSignals - B353LP12511

Wearable Biosensor - ECG Remote Monitoring Biosensor
Lifesignals, Inc.
LP1251
In Commercial Distribution

  • B353LP12511 ()
LP1251_US

  • Electrocardiographic ambulatory recorder

LifeSignals - B353LP12501

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

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


  • Electrocardiographic ambulatory recorder

Advance Biometrix - B353AB12511

Wearable Biosensor - ECG Remote Monitoring Biosensor
Lifesignals, Inc.
AB1251
Not in Commercial Distribution

  • B353AB12512 ()
  • B353AB12511 ()
  • B353AB12513 ()
AB1251_US

  • Electrocardiographic ambulatory recorder

Diversatek Healthcare - 00816734022405

Non-Infused Single-Use Z/pH Probe (External Reference), Single pH (Esophageal)
DIVERSATEK HEALTHCARE, INC.
ZPN-BS-46E
In Commercial Distribution

  • 00816734022405 ()
  • B019ZPNBS46E0 ()

  • Catheter Gauge: 6.4 French
ZPN-BS-46E

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734022382

Non-Infused Single-Use Z/pH Probe (External Reference), Dual pH (Gastric & Esophageal)
DIVERSATEK HEALTHCARE, INC.
ZPN-BG-07E
In Commercial Distribution

  • 00816734022382 ()
  • B019ZPNBG07E0 ()

  • Catheter Gauge: 6.4 French
ZPN-BG-07E

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734022368

Infused Single-Use Z/pH Probe (Internal Reference), Single pH (Esophageal) with LES Locator, Locator Port 6cm
DIVERSATEK HEALTHCARE, INC.
ZPI-BS-46
In Commercial Distribution

  • 00816734022368 ()
  • B019ZPIBS460 ()

  • Catheter Gauge: 6.9 French
ZPI-BS-46

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734022337

Non-Infused Single-Use Z/pH Probe (External Reference), Single pH (Esophageal)
DIVERSATEK HEALTHCARE, INC.
ZIN-BS-45E
In Commercial Distribution

  • 00816734022337 ()
  • B019ZINBS45E0 ()

  • Catheter Gauge: 6.4 French
ZIN-BS-45E

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734022313

Single-Use Z/pH Probe (External Reference), Single pH (Esophageal)
DIVERSATEK HEALTHCARE, INC.
ZAN-BS-01E
In Commercial Distribution

  • 00816734022313 ()
  • B019ZANBS01E0 ()

  • Catheter Gauge: 6.4 French
ZAN-BS-01E

  • Manometric gastrointestinal motility analysis system
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