TeleSense Software

GUDID 00856298006213

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

SCOTTCARE CORPORATION, THE

Electrocardiographic long-term ambulatory recording analyser application software

• Primary Device ID: 00856298006213
• NIH Device Record Key: 4ef566bc-a050-40d1-80d4-3bcd30b76457
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TeleSense Software
• Version Model Number: TeleSense Software
• Company DUNS: 808204957
• Company Name: SCOTTCARE CORPORATION, THE
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 216-362-0550
• Email: service@scottcare.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856298006213 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142180

FDA Product Code

• DRG: Transmitters And Receivers, Physiological Signal, Radiofrequency

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-19

Devices Manufactured by SCOTTCARE CORPORATION, THE

• 00856298006428 - EZLink-R: 2024-05-31
• 00856298006435 - EZLink-C: 2024-05-31
• 00856298006008 - Chroma: 2019-11-08 The Chroma model RZ153C Holter monitor is a battery operated solid-state recorder. It is designed for up to 48 hours (2 days) co
• 00856298006015 - Chroma2: 2019-11-08
• 00856298006022 - TeleSenseRCM: 2019-11-08 The TeleSense device is intended for diagnostic evaluation of patients who experience transient symptoms or asymptomatic events
• 00856298006039 - TeleSense-E: 2019-11-08 The TeleSense device is intended for diagnostic evaluation of patients who experience transient symptoms or asymptomatic events
• 00856298006220 - Chroma 5 Lead Patient Cable: 2019-11-08 5 lead ECG patient cable to be used with the Chroma device.
• 00856298006312 - Chroma 7 Lead Patient Cable: 2019-11-08 7 lead ECG patient cable to be used with the Chroma device.