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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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The Electrode Store - 00816022020205

Disposable Stim Needle Electrodes, 12mm(.5")x23ga Coated (5 Red, 5 Black)
IMPULSE MEDICAL TECHNOLOGIES, INC.
JO-5DTSAF
In Commercial Distribution

  • 00816022020205 ()
JO-5DTSAF

  • Electromyographic needle electrode, single-use

The Electrode Store - 00816022020199

Disposable Stim Needle Electrodes, 12mm(.5")x23ga Uncoated(5 Red, 5 Black)
IMPULSE MEDICAL TECHNOLOGIES, INC.
JO-5DSAF
In Commercial Distribution

  • 00816022020199 ()
JO-5DSAF

  • Electromyographic needle electrode, single-use

ADVIA Centaur® Systems EHIV QC - 00630414509372

HIV 1/O/2 Enhanced (EHIV) Quality Control Material Kit
Siemens Healthcare Diagnostics Inc.
10309010
Not in Commercial Distribution

  • 00630414509372 ()
1324827

  • HIV1/HIV2 antibody IVD, control

ARCHITECT - 00380740003906

ARCHITECT HIV Ag/Ab Combo Reagent Kit
Abbott GmbH
2P36-35
In Commercial Distribution

  • 00380740003906 ()
02P3635

  • HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay

ARCHITECT - 00380740003890

ARCHITECT HIV Ag/Ab Combo Reagent Kit
Abbott GmbH
2P36-25
In Commercial Distribution

  • 00380740003890 ()
02P3625

  • HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay

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

ImagineMed - B353IM12101

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

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


  • 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
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