EventCare 100792

GUDID 00856298006190

The EventCare Event Monitoring System allows for the performance of traditional acoustic arrhythmia monitoring and the utilization of cellular event transmissions and monitoring. The system helps to maintain an accurate inventory of devices, patients’ records ECG events and reports. The system can also produce a wide array of administrative reports to help manage your monitoring operations. This program provides fast, accurate access to your patients’ events and Electrocardiographic recordings, regardless of time or location. EventCare allows you to receive live or recorded ECG transmissions over ordinary telephone lines, as well as cellular telephony networks, edit the ECG right on the computer screen, then print out a detailed, professional report.

SCOTTCARE CORPORATION, THE

Cardiology information system application software

• Primary Device ID: 00856298006190
• NIH Device Record Key: 97b7364f-d4ea-4ee4-8d0e-19dae3b62743
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EventCare
• Version Model Number: EventCare
• Catalog Number: 100792
• 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	00856298006190 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061780

FDA Product Code

• DXH: Transmitters And Receivers, Electrocardiograph, Telephone

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

• 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.
• 00856298006053 - Angel: 2019-05-07 Cardiac Rehab ECG telemetry transmitter.
• 00856298006060 - Innovo: 2019-05-07 Cardiac Rehab ECG telemetry transmitter.