TeleSense Software

Basic Information

• Brand Name: TeleSense Software
• Primary DI: 00856298006213
• Version / Model: TeleSense Software
• Company Name: SCOTTCARE CORPORATION, THE
• Labeler DUNS: 808204957
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-19
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 4ef566bc-a050-40d1-80d4-3bcd30b76457

Device Description

Software used for interaction and programming of the TeleSenseRCM and TeleSense-E devices.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	870.2910	2

GMDN Terms

Code	Name	Definition	Implantable	Status
41651	Electrocardiographic long-term ambulatory recording analyser application software	A dedicated application data program designed for use in, or together with, an electrocardiographic long-term ambulatory recording analyser so that this may function according to its intended purpose. This software program can be permanently installed, or exchanged as an upgrade. It may also be produced for installation in an off-the-shelf desktop or laptop computer.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00856298006213	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K142180	000