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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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TeleSenseRCM - 00856298006022

The TeleSense device is intended for diagnostic evaluation of patients who experience transient symptoms or asymptomatic events that may suggest cardiac arrhythmia. The device continuously monitors and records the data, automatically records events triggered by an arrhythmia detection algorithm or manually by the patient, and automatically transmits the recorded event activity associated with these symptoms for review by a licensed physician. The TeleSense is a battery powered device to be used to measure, record, store and/or remotely transfer the Electrocardiogram (ECG) noninvasively in mobile patients. The available data transfer methods are USB and Wi-Fi. TeleSense is not limited to certain patient groups or pathologies; however, the TeleSense is not intended for pediatric use. Examples of applications are: - Cardiology - Pulmonary Care - Home Care - General Practitioners Contraindications: a. Patients with potentially life-threatening arrhythmias who require inpatient monitoring. b. Patients who the attending physician thinks should be hospitalized.
SCOTTCARE CORPORATION, THE
MCT1774
In Commercial Distribution

  • 00856298006022 ()
101838

  • Telemetric electrocardiographic ambulatory recorder

GN Hearing - 05708296137121

CROS,SUREFIT,AUDIO SHOE,LGE
Gn Hearing A/S
20041100
In Commercial Distribution

  • 05708296137121 ()


  • Hearing aid/implant system functionality-enhancing device

GN Hearing - 05708296137114

CROS,SUREFIT,AUDIO SHOE,MDM
Gn Hearing A/S
20041000
In Commercial Distribution

  • 05708296137114 ()


  • Hearing aid/implant system functionality-enhancing device

GN Hearing - 05708296137107

CROS,SUREFIT,AUDIO SHOE,SM
Gn Hearing A/S
20040900
In Commercial Distribution

  • 05708296137107 ()


  • Hearing aid/implant system functionality-enhancing device

GN Hearing - 05708296137046

AUD SHOE BIGNANO CLR COMPL
Gn Hearing A/S
511-007-000-00
In Commercial Distribution

  • 05708296137046 ()


  • Hearing aid/implant system functionality-enhancing device

GN Hearing - 05708296136995

AUD SHOE QUANTUM ST-GRA COMPL
Gn Hearing A/S
511-004-000-06
In Commercial Distribution

  • 05708296136995 ()


  • Hearing aid/implant system functionality-enhancing device

GN Hearing - 05708296136988

AUD SHOE QUANTUM GRA COMPL
Gn Hearing A/S
511-004-000-03
In Commercial Distribution

  • 05708296136988 ()


  • Hearing aid/implant system functionality-enhancing device

GN Hearing - 05708296136964

AUD SHOE SUPREMA/SUPRA GRA
Gn Hearing A/S
511-003-000-03
In Commercial Distribution

  • 05708296136964 ()


  • Hearing aid/implant system functionality-enhancing device

GN Hearing - 05708296136940

AUD SHOE SUPREMA/SUPRA BGE
Gn Hearing A/S
511-003-000-01
In Commercial Distribution

  • 05708296136940 ()


  • Hearing aid/implant system functionality-enhancing device

GN Hearing - 05708296136902

AUD SHOE MP PULL BGE COMPL
Gn Hearing A/S
511-002-000-01
In Commercial Distribution

  • 05708296136902 ()


  • Hearing aid/implant system functionality-enhancing device
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