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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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Sirona - 00851074007125

Sirona B PC App
DATRIX LLC
RX22673
In Commercial Distribution

  • 00851074007125 ()


  • Telemetric electrocardiographic ambulatory recorder

Performer + - 00851074007118

ECG Recorder
DATRIX LLC
RX92887-000
In Commercial Distribution

  • 00851074007118 ()


  • Telemetric electrocardiographic ambulatory recorder

Sirona - 00851074007101

Smart Dock
DATRIX LLC
RX92864-000
In Commercial Distribution

  • 00851074007101 ()


  • Telemetric electrocardiographic ambulatory recorder

Sirona - 00851074007088

Generic Sirona Kit
DATRIX LLC
RX93051-000
Not in Commercial Distribution

  • 00851074007088 ()


  • Telemetric electrocardiographic ambulatory recorder

Sirona - 00851074007002

ECG Recorder
DATRIX LLC
RX93030-000
In Commercial Distribution

  • 00851074007002 ()


  • Telemetric electrocardiographic ambulatory recorder

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

Polytel GMA - 00861700000314

Glucose meter accessory providing Bluetooth connectivity to glucose meters manufactured by Bayer. Specific meters supported are Breeze2, Contour, Contour TS, Contour next EZ.
Polymap Wireless
PWR-08-07
In Commercial Distribution

  • 00861700000314 ()


  • Medical networking interface unit

GD - 00862186000386

The Rosetta-Lt Data Translator receives and communicates information from monitor/defibrillators over radio/phone communications systems.
General Devices
Rosetta-Lt Data Translator
Not in Commercial Distribution

  • 00862186000386 ()
040-184-7100

  • Medical networking interface unit

GD - 00862186000379

The CAREpoint Workstation (Version 1 and 2) communication console is a standard radio/telephony communications console used for vice and data communications. Personal Computer (PC) based, it contains various means to interface to and control communications elements (i.e. 2 way radio, landline, wireless telephone) as which are commonly used for commercial and public safety (i.e. police, fire, EMS) communication purposes.
General Devices
CAREpoint Workstation
Not in Commercial Distribution

  • 00862186000379 ()
040-183-4000

  • Medical networking interface unit

Polytel - 00861700000376

Glucose Meter Accessory for existing glucose meters from LifeScan, providing Bluetooth 2.1 connectivity for telehealth applications. This is built on a PWR-09-02 device, which an also support other glucose meter families if appropriate cables are provided: "B" cable: Bayer Breeze2, Contour, Contour TS, Contour XT, Contour next EZ, "A" cable: Abbott FreeStyle Lite, FreeStyle Freedom Lite
Polymap Wireless
GMA2-L
In Commercial Distribution

  • 00861700000376 ()


  • Medical networking interface unit
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