OneView

Basic Information

• Brand Name: OneView
• Primary DI: 00856298006206
• Version / Model: OneView
• Catalog Number: 101247
• Company Name: SCOTTCARE CORPORATION, THE
• Labeler DUNS: 808204957
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-19
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 0c938f1f-992c-42b1-99f9-ca16b39fb29f

Device Description

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

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DXH	Transmitters And Receivers, Electrocardiograph, Telephone	Cardiovascular	870.2920	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00856298006206	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K061780	000