DEVICE: TeleSenseRCM (00856298006022)

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Device Identifier (DI) Information

TeleSenseRCM
MCT1774
101838
SCOTTCARE CORPORATION, THE
00856298006022
GS1
1
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.
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Electrocardiographic long-term ambulatory recorder, telemetric An automated, battery-powered, device intended to be used for the 24-hour registration of a patient's heart activity and the wireless transmission of the registered electrocardiogram (ECG) to a receiver/analysis system. The patient is connected to and wears the device during the recording period and/or while he or she performs normal daily activities. The recording is analysed at a medical facility using an electrocardiographic Holter analyser or a computer, with dedicated software.
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FDA Product Code

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Product Code Product Code Name
DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
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Sterilization

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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: between -20 and 40 Degrees Celsius
Handling Environment Temperature: between -20 and 40 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
September 19, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
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Yes
No CLOSE

Customer Contact

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216-362-0550
service@scottcare.com
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