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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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Holter Kit (Wi-Fi Only) - 00850490007511

Contains VistaPhone (Wi-Fi Only) with protective case, charger, charge cable, Adhesive Overlay, Alcohol Wipes, Adhesive Removal Pads
Vital Connect, Inc.
2400-01
In Commercial Distribution

  • 00850490007511 ()
2400-01

  • Telemetric electrocardiographic ambulatory recorder

Visix - 00851800007092

Visix software for use with just an intraoral camera version 2.3.10
TELEVERE SYSTEMS, LLC
for Intraoral Camera 2.3.10
In Commercial Distribution

  • 00851800007092 ()
Visix for Intraoral Camera 2.3.10

  • Camera application software
  • Radiological PACS software

TLC Diagnostics - 00851074007392

ECG recorder
DATRIX LLC
TLC 1-Stop Alert
In Commercial Distribution

  • 00851074007392 ()
RX93030-013

  • Telemetric electrocardiographic ambulatory recorder

CardioLabs - 00851074007385

ECG Recorder (Event)
DATRIX LLC
Sirona
In Commercial Distribution

  • 00851074007385 ()
RX93030-012

  • Telemetric electrocardiographic ambulatory recorder

Zywie - 00851074007378

ECG recorder
DATRIX LLC
Sirona
In Commercial Distribution

  • 00851074007378 ()
RX93030-011

  • Telemetric electrocardiographic ambulatory recorder

CardioDiagnostics - 00851074007354

ECG Recorder
DATRIX LLC
Lifesense mini
In Commercial Distribution

  • 00851074007354 ()
RX93030-006

  • Telemetric electrocardiographic ambulatory recorder

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
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