DEVICE: OneView (00856298006206)

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Device Identifier (DI) Information

OneView
OneView
101247
SCOTTCARE CORPORATION, THE
00856298006206
GS1
1
ScottCare’s OneView is an innovative, cardiology software tool used to simplify and streamline the pacemaker/ICD monitoring session reporting process by consolidating all device manufacturers’ session data into one, convenient platform. With a click of a button, OneView captures all relevant pacemaker/ICD data, including:  Device specifications  Measurements for every session  Settings  Episode details  Reports  Physician sign-off OneView also provides insight into historical patient trends and other critical clinical data over time, helping to prioritize patients with more severe issues. In addition, data can be gathered from almost anywhere, as it supports remote interrogation, in-person interrogation and in-person programming.
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Device Characteristics

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

GMDN

[?]

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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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 Status

In Commercial Distribution
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)

[?]
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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