Duns Number:008171162
Device Description: The GLUCOCARD Shine XL Blood Glucose Monitoring System is intended for the quantitative me The GLUCOCARD Shine XL Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in freshcapillary whole blood samples drawn from the fingertips and alternative sites such as the forearm, palm, thigh and calf.
Catalog Number
-
Brand Name
GLUCOCARD® Shine XL Blood Glucose Monitoring System
Version/Model Number
542110
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"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K083468,K083468,K083468
Product Code
NBW
Product Code Name
System, Test, Blood Glucose, Over The Counter
Public Device Record Key
83dd5e77-622f-4ddb-b6fc-22865cf26512
Public Version Date
January 03, 2019
Public Version Number
4
DI Record Publish Date
September 12, 2017
Package DI Number
20015482542102
Quantity per Package
16
Contains DI Package
10015482542105
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master Case
| 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 |