AccessGUDID - DEVICE: TeleSenseRCM (00856298006022)

GUDID

Device Identifier (DI) Information

Brand Name: TeleSenseRCM
Version or Model: MCT1774
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 101838
Company Name: SCOTTCARE CORPORATION, THE

Primary DI Number: 00856298006022
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 808204957 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
38729	Telemetric electrocardiographic ambulatory recorder	An electrically-powered, noninvasive device designed to be worn by a patient during daily activities for 24-hour recording of the electrocardiographic signals of the heart, for the diagnosis of cardiac disorders (e.g., arrhythmias). The recorded measurements can be wirelessly transmitted and analysed, typically to a remote computer with a dedicated software located at a medical facility. Otherwise known as a Holter monitor, the device typically incorporates display and controls, and may include surface electrodes, lead wires and accessories intended for attachment/removal (e.g., wipes, adhesive remover).	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K142180	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9b5f5e82-4973-4ad6-8afd-292fba00472d
Public Version Date: November 08, 2019
Public Version Number: 4
DI Record Publish Date: September 19, 2016