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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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Leica Biosystems CytoVision K/F Station w/ Jai MV4 Camera
Leica Biosystems Richmond, Inc.
23CAP001KFX001
Not in Commercial Distribution

  • 00849832003366 ()

  • Device Size Text, specify:


  • Cell morphology analyser IVD, automated/semi-automated
Leica Biosystems CytoVision MB8 scanning system for Karyotyping
Leica Biosystems Richmond, Inc.
23MBX008KXX001
Not in Commercial Distribution

  • 00849832003359 ()

  • Device Size Text, specify:


  • Cell morphology analyser IVD, automated/semi-automated
Leica Biosystems CytoVision MB8 scanning system for Karyotyping &FISH
Leica Biosystems Richmond, Inc.
23MBX008KFX001
Not in Commercial Distribution

  • 00849832003342 ()

  • Device Size Text, specify:


  • Cell morphology analyser IVD, automated/semi-automated
Leica Biosystems CytoVision GSL120 scanning system for Karyotyping
Leica Biosystems Richmond, Inc.
23GSL120KXX001
In Commercial Distribution

  • 00849832003335 ()

  • Device Size Text, specify:


  • Cell morphology analyser IVD, automated/semi-automated
Leica Biosystems CytoVision GSL120 scanning system Karyotyping & FISH
Leica Biosystems Richmond, Inc.
23GSL120KFX001
Not in Commercial Distribution

  • 00849832003328 ()

  • Device Size Text, specify:


  • Cell morphology analyser IVD, automated/semi-automated
Leica Biosystems CytoVision GSL10 scanning system for Karyotyping
Leica Biosystems Richmond, Inc.
23GSL10XKXX001
Not in Commercial Distribution

  • 00849832003311 ()

  • Device Size Text, specify:


  • Cell morphology analyser IVD, automated/semi-automated
Leica Biosystems CytoVision GSL10 scanning sys for Karyotyping &FISH
Leica Biosystems Richmond, Inc.
23GSL10XKFX001
Not in Commercial Distribution

  • 00849832003304 ()

  • Device Size Text, specify:


  • Cell morphology analyser IVD, automated/semi-automated
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SAKURA FINETEK U.S.A., INC.
9023
In Commercial Distribution

  • 00615233082404 ()
9023

  • Cell morphology analyser IVD, automated/semi-automated
The Rhythm Express RX-1 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 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 incorporates a cellular modem to communicate with the RS-1 Web Service. The RX-1 device uses an embedded cellular modem on the Verizon LTE network. The RX-1 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
In Commercial Distribution

  • 00860000272414 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
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
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