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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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Software used for interaction and programming of the TeleSenseRCM and TeleSense-E devices.
SCOTTCARE CORPORATION, THE
TeleSense Software
In Commercial Distribution

  • 00856298006213 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
Software used for the interaction and programming of the Novi Device.
SCOTTCARE CORPORATION, THE
Novi Software
In Commercial Distribution

  • 00856298006237 ()
101633

  • Electrocardiographic long-term ambulatory recording analyser application software
SPEEDLINK UNIT
Gn Hearing A/S
15874200
In Commercial Distribution

  • 05708296137428 ()


  • Hearing aid/implant system programming interface unit
1072 HI-PRO 2
Natus Medical Denmark ApS
Hearing Instrument Programmer
In Commercial Distribution

  • 05713315000331 ()
8-04-14800

  • Hearing aid/implant system programming interface unit
The Rhythm Express RX-1 mini will be worn by adult patients for a period of time as prescribed by a physician, typically 1 day to 4 weeks, and will continuously monitor ECG. RX-1 mini will function in one of three modes: a) Mobile Cardiac Telemetry (MCT), b) Event Recorder (ER), and Wireless Holter (WH). The device will connect to standard ECG electrodes to capture 2 channel ECGs. An embedded algorithm processes the acquired ECG to detect arrhythmias, compress the ECG, and remove most in-band noise without distorting ECG morphology. RX-1 mini incorporates a cellular modem to communicate with the RS-1 Web Service. The RX-1 mini device uses an embedded cellular modem on the cellular network. The RX-1 mini device is not a life-supporting or life-sustaining system. Clinical judgment and experience are used to check and interpret the data.
VIVAQUANT, INC.
RX-1 mini
In Commercial Distribution

  • 00860000272407 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
No Description
Interacoustics A/S
Viot Suite
In Commercial Distribution

  • 05711117199765 ()


  • Camera application software
No Description
Interacoustics A/S
2D-VOGfw
In Commercial Distribution

  • 05711117180497 ()


  • Camera application software
HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Turnkey system with configured CPU and color LCD 24" monitor with 1920 x 1080 resolution; US power cord; HP LaserJet 110V printer; Rx Report Export (UNIPRO and waveform XML) + XML Orders
WELCH ALLYN, INC.
901143
Not in Commercial Distribution

  • 00732094327496 ()
HSCRIBE-6AA-AAXXD

  • Electrocardiographic long-term ambulatory recording analyser application software
HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Software activation only; No power cord, activation only; No printer; Rx Report Export (UNIPRO and waveform XML) + DICOM bidirectional Interface
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094325607 ()
HSCRIBE-6AD-ZXXXE

  • Electrocardiographic long-term ambulatory recording analyser application software
HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Software kit; Australia power cord; No printer; Rx Report Export (UNIPRO and waveform XML) + DICOM bidirectional Interface
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094325591 ()
HSCRIBE-6AC-BXXXE

  • Electrocardiographic long-term ambulatory recording analyser application software
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