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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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A.C.T. (American Cardiac Telemetry) - 00851074007347

ECG Holter Recorder
DATRIX LLC
Sirona
In Commercial Distribution

  • 00851074007347 ()
RX93030-008

  • Telemetric electrocardiographic ambulatory recorder

A.C.T. (American Cardiac Telemetry) - 00851074007330

ECG Event Recorder
DATRIX LLC
Sirona
In Commercial Distribution

  • 00851074007330 ()
RX93030-009

  • Telemetric electrocardiographic ambulatory recorder

Heart Smart - 00851074007323

ECG Recorder
DATRIX LLC
Sirona
In Commercial Distribution

  • 00851074007323 ()
RX93030-007

  • Telemetric electrocardiographic ambulatory recorder

Broomwell - 00851074007293

Sirona PC App
DATRIX LLC
Sirona
In Commercial Distribution

  • 00851074007293 ()
RX22773-004

  • Telemetric electrocardiographic ambulatory recorder

HeartcoR - 00851074007262

Cardiac Monitor / ECG Recorder
DATRIX LLC
Sentinel
In Commercial Distribution

  • 00851074007262 ()
RX93030-005

  • Telemetric electrocardiographic ambulatory recorder

AMI - 00851074007255

Sirona PC App
DATRIX LLC
Sirona
In Commercial Distribution

  • 00851074007255 ()
RX22773-002

  • Telemetric electrocardiographic ambulatory recorder

CardioLabs - 00851074007248

Sirona PC App
DATRIX LLC
Sirona
In Commercial Distribution

  • 00851074007248 ()
RX22773-001

  • Telemetric electrocardiographic ambulatory recorder

AMI - 00851074007231

Sirona Android App
DATRIX LLC
Sirona
In Commercial Distribution

  • 00851074007231 ()
RX22711-002

  • Telemetric electrocardiographic ambulatory recorder

CardioLabs - 00851074007224

Sirona Android App
DATRIX LLC
Sirona
In Commercial Distribution

  • 00851074007224 ()
RX22711-001

  • Telemetric electrocardiographic ambulatory recorder

Broomwell - 00851074007200

Cardiac Monitor / ECG Recorder
DATRIX LLC
Sirona
In Commercial Distribution

  • 00851074007200 ()
RX93030-004

  • Telemetric electrocardiographic ambulatory recorder
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