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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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ZOLL Arrhythmia Management System - 00855778005463

No Description
ZOLL MANUFACTURING CORPORATION
Gateway (4G)
In Commercial Distribution

  • 00855778005463 ()
10A1112

  • Wearable multiple vital physiological parameter monitoring system

uCor Heart Failure and Arrhythmia Management System - 00855778005456

No Description
ZOLL MANUFACTURING CORPORATION
Gateway (4G)
In Commercial Distribution

  • 00855778005456 ()
10A1107

  • Wearable multiple vital physiological parameter monitoring system

ZOLL Arrhythmia Management System - 00855778005364

No Description
ZOLL MANUFACTURING CORPORATION
Gateway
In Commercial Distribution

  • 00855778005364 ()
10A1088

  • Wearable multiple vital physiological parameter monitoring system

ZOLL Arrhythmia Management System - 00855778005357

No Description
ZOLL MANUFACTURING CORPORATION
Sensor
In Commercial Distribution

  • 00855778005357 ()
10A1087

  • Wearable multiple vital physiological parameter monitoring system

uCor Heart Failure and Arrhythmia Management System - 00855778005326

No Description
ZOLL MANUFACTURING CORPORATION
Gateway
In Commercial Distribution

  • 00855778005326 ()
10A1073

  • Wearable multiple vital physiological parameter monitoring system

ZOLL Charger - 00855778005319

No Description
ZOLL MANUFACTURING CORPORATION
Charger
In Commercial Distribution

  • 00855778005319 ()
10A1072

  • Wearable multiple vital physiological parameter monitoring system

uCor Heart Failure and Arrhythmia Management System - 00855778005302

No Description
ZOLL MANUFACTURING CORPORATION
Sensor
In Commercial Distribution

  • 00855778005302 ()
10A1071

  • Wearable multiple vital physiological parameter monitoring system

ZOLL Patch - 00855778005258

No Description
ZOLL MANUFACTURING CORPORATION
Patch
In Commercial Distribution

  • 00855778005258 ()
10A1067

  • Wearable multiple vital physiological parameter monitoring system

Iradimed - 00856038001218

MRI Monitor Remote Base/Charger
IRADIMED CORP.
3885B
In Commercial Distribution

  • 00856038001218 ()
3885B

  • Centralized patient monitor

AcQMap - 00857042007999

AcQMap System
ACUTUS MEDICAL, INC.
900000
Not in Commercial Distribution

  • 00857042007999 ()
900000

  • Cardiac mapping system
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