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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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Transtelephonic receiving module for transtelephonic devices.
SCOTTCARE CORPORATION, THE
Transtelephonic Receiving Module
In Commercial Distribution

  • 00856298006114 ()
100151

  • Medical networking interface unit
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
E1774
In Commercial Distribution

  • 00856298006039 ()
101839

  • Telemetric electrocardiographic ambulatory recorder
AUDIOSHOE,SP,WITH BGE BAT DR
Gn Hearing A/S
15349000
In Commercial Distribution

  • 05708296136315 ()


  • Hearing aid/implant system functionality-enhancing device
AI-SHOE, MIA
Gn Hearing A/S
15345100
In Commercial Distribution

  • 05708296136308 ()


  • Hearing aid/implant system functionality-enhancing device
AUDIOLID,PED,LABLD,OLV,BT5
Gn Hearing A/S
12272-038
In Commercial Distribution

  • 05708296136285 ()


  • Hearing aid/implant system functionality-enhancing device
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
CROS,SUREFIT,AUDIO SHOE,LGE
Gn Hearing A/S
20041100
In Commercial Distribution

  • 05708296137121 ()


  • Hearing aid/implant system functionality-enhancing device
CROS,SUREFIT,AUDIO SHOE,MDM
Gn Hearing A/S
20041000
In Commercial Distribution

  • 05708296137114 ()


  • Hearing aid/implant system functionality-enhancing device
CROS,SUREFIT,AUDIO SHOE,SM
Gn Hearing A/S
20040900
In Commercial Distribution

  • 05708296137107 ()


  • Hearing aid/implant system functionality-enhancing device
AUD SHOE BIGNANO CLR COMPL
Gn Hearing A/S
511-007-000-00
In Commercial Distribution

  • 05708296137046 ()


  • Hearing aid/implant system functionality-enhancing device
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