Duns Number:008171162
Device Description: ARK Care Advance is a Diabetes Management System that is a solution for people with diabet ARK Care Advance is a Diabetes Management System that is a solution for people with diabetes to upload and store their blood glucose readings from their blood glucose meters (BGMs). The system also allows healthcare providers to access their patients’ logbooks and BGM data, which could help increase the effectiveness of care and improve outcomes.
Catalog Number
-
Brand Name
ARK Care® Advance Diabetes Management System
Version/Model Number
Ver 2.0.
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 17, 2020
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"
-
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
-
Product Code
JQP
Product Code Name
Calculator/Data Processing Module, For Clinical Use
Public Device Record Key
c757475b-9d44-431e-ba7f-a4508955b0c7
Public Version Date
December 18, 2020
Public Version Number
2
DI Record Publish Date
March 12, 2020
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 30 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 50 |