DEVICE: EventCare (00856298006190)

Device Identifier (DI) Information

EventCare
EventCare
In Commercial Distribution
100792
SCOTTCARE CORPORATION, THE
00856298006190
GS1

1
808204957 *Terms of Use
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.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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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FDA Product Code

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Product Code Product Code Name
DXH Transmitters And Receivers, Electrocardiograph, Telephone
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

97b7364f-d4ea-4ee4-8d0e-19dae3b62743
March 29, 2018
2
September 19, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
No
No
No CLOSE

Customer Contact

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216-362-0550
service@scottcare.com
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