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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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OvuSense - 05060508530114

OvuSense 2 App - Android
VIO HEALTHTECH LIMITED
M032 Android
In Commercial Distribution

  • 05060508530114 ()


  • Thermometric fertility analyser

OvuSense - 05060508530107

OvuSense 2 App - iOS
VIO HEALTHTECH LIMITED
M032 iOS
In Commercial Distribution

  • 05060508530107 ()


  • Thermometric fertility analyser

Seer Home - 09355751001235

Seer App: Epilepsy Management
SEER MEDICAL HOLDINGS LIMITED
Seer App: Epilepsy Management
Not in Commercial Distribution

  • 09355751001235 ()


  • Electroencephalograph

CARDINAL HEALTH - 10888439303599

ALLENTOWN LAP CHOLE APP
Cardinal Health 200, LLC
SLC11LLSL1
In Commercial Distribution

  • 50888439303597 ()
  • 10888439303599 ()
SLC11LLSL1

  • Laparoscopic surgical procedure kit, non-medicated, single-use

Medline - 10080196403998

PUMP,REPLACEMENT,APP,AIRONE
MEDLINE INDUSTRIES, INC.
MSCAOPUMP
In Commercial Distribution

  • 10080196403998 ()
MSCAOPUMP

  • Alternating-pressure inflator

Sirona - 00851074007149

Sirona B Android App
DATRIX LLC
RX22711
In Commercial Distribution

  • 00851074007149 ()


  • Telemetric electrocardiographic ambulatory recorder

Sirona - 00851074007132

Sirona B iOS App
DATRIX LLC
RX22674
In Commercial Distribution

  • 00851074007132 ()


  • Telemetric electrocardiographic ambulatory recorder

Sirona - 00851074007125

Sirona B PC App
DATRIX LLC
RX22673
In Commercial Distribution

  • 00851074007125 ()


  • Telemetric electrocardiographic ambulatory recorder

TempTraq® - 00851203006128

TempTraq Clinician Android App
BLUE SPARK TECHNOLOGIES, INC.
TempTraq Clinician Android App
Not in Commercial Distribution

  • 00851203006128 ()


  • Wireless patient monitor/sensor reporting software, layperson-use

TempTraq - 00851203006043

TempTraq Consumer iOS App
BLUE SPARK TECHNOLOGIES, INC.
TempTraq Consumer iOS App
Not in Commercial Distribution

  • 00851203006043 ()


  • Wireless patient monitor/sensor reporting software, layperson-use
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