DEVICE: EventCare (00856298006190)
Device Identifier (DI) Information
EventCare
EventCare
In Commercial Distribution
100792
SCOTTCARE CORPORATION, THE
EventCare
In Commercial Distribution
100792
SCOTTCARE CORPORATION, THE
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.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
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No | |
No | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
44098 | Cardiology information system application software |
An application software program, routines, and/or algorithms intended to be used as or in an information system to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the administrative and clinical activities associated with the provision and utilization of cardiology services and facilities. It is typically supplied for installation into a dedicated information system for cardiology or existing mainframe or decentralized computers/networks.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DXH | Transmitters And Receivers, Electrocardiograph, Telephone |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K061780 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
97b7364f-d4ea-4ee4-8d0e-19dae3b62743
July 06, 2018
3
September 19, 2016
July 06, 2018
3
September 19, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
216-362-0550
service@scottcare.com
service@scottcare.com