DEVICE: Epiphany Cardio Server (00086099100300)

Device Identifier (DI) Information

Epiphany Cardio Server
5.1.0
In Commercial Distribution

EPIPHANY HEALTHCARE DATA MANAGEMENT, LLC
00086099100300
GS1

1
079747524 *Terms of Use
ECG Management System is a software only EGG management database that stores, displays, and prints high resolution EGG data
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
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
DQK Computer, Diagnostic, Programmable
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K052883 000
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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

7cf0d760-10f5-494d-8082-24e18b7b179b
July 06, 2018
3
September 09, 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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No
No
No
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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