Duns Number:808204957
Device Description: ScottCare’s OneView is an innovative, cardiology software tool used to simplify and stream ScottCare’s OneView is an innovative, cardiology software tool used to simplify and streamline thepacemaker/ICD monitoring session reporting process by consolidating all device manufacturers’ session datainto 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-offOneView also provides insight into historical patient trends and other critical clinical data over time, helping toprioritize patients with more severe issues. In addition, data can be gathered from almost anywhere, as itsupports remote interrogation, in-person interrogation and in-person programming.
Catalog Number
101247
Brand Name
OneView
Version/Model Number
OneView
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
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For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K061780
Product Code
DXH
Product Code Name
Transmitters And Receivers, Electrocardiograph, Telephone
Public Device Record Key
0c938f1f-992c-42b1-99f9-ca16b39fb29f
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 19, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 32 |