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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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It's designed for family and individual users to track heart activity at home, at work or on a trip in case of cardiac situation that needs evaluation on the spot.
EMAY (HK) LIMITED
EMG-6L
In Commercial Distribution

  • 04897087206120 ()


  • Telemetric electrocardiographic ambulatory recorder
Workstation Assembly
Lumicell, Inc.
810-00217
In Commercial Distribution

  • 00860003252543 ()
  • 00860008537805 ()


  • Intraoperative tumour margin fluorescence imaging system
Light source
Lumicell, Inc.
810-00212
In Commercial Distribution

  • 00860003252598 ()
  • 00860003252536 ()


  • Intraoperative tumour margin fluorescence imaging system
No Description
Canary Medical USA LLC
43-5570-005-14
In Commercial Distribution

  • 00860003118368 ()


  • Medical networking interface unit
The CTE with CHIRP Base Station subsystem is a unit with embedded firmware that facilitate communication with the CTE implant to serve as a conduit for implant data transmission in the environments where it will be used. The Home Base Station subsystem is for use by the Patient.
Canary Medical USA LLC
43-5570-001-14
In Commercial Distribution

  • 00860003118320 ()


  • Medical networking interface unit
The OR Base Station subsystem is intended to send and receive data to and from the CTE implant over a wireless communication interface. Data sent to the CTE implant from the OR Base Station activates the CTE implant on the day of surgery.
Canary Medical USA LLC
43-5570-002-14
In Commercial Distribution

  • 00860003118313 ()


  • Medical networking interface unit
Brand-independent integration with Ceiba eConnect APIs of medical devices (monitors, respirators, pumps, blood gas) and hospital systems
Ceiba Healthcare Technologies LLC
ECONNECT IoMT Box
In Commercial Distribution

  • 00860006137014 ()


  • Medical networking interface unit
Transtelephonic receiving module for transtelephonic devices.
SCOTTCARE CORPORATION, THE
Transtelephonic Receiving Module
In Commercial Distribution

  • 00856298006114 ()
100151

  • Medical networking interface unit
Wireless Adapter
Thoratec Corporation
HMT2100
In Commercial Distribution

  • 05415067032065 ()
HMT2100

  • Medical networking interface unit
Mobile Application
ST. JUDE MEDICAL, INC.
APP1001
In Commercial Distribution

  • 05415067027405 ()
APP1001

  • Implantable cardiac monitor programmer/transmitter/alarm
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