DEVICE: OneView (00856298006206)
Device Identifier (DI) Information
OneView
OneView
In Commercial Distribution
101247
SCOTTCARE CORPORATION, THE
OneView
In Commercial Distribution
101247
SCOTTCARE CORPORATION, THE
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.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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.
|
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 |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
0c938f1f-992c-42b1-99f9-ca16b39fb29f
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 |
---|---|
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