Duns Number:008171162
Device Description: Startup Portable Blood Glucose Meter System. Includes: blood glucose meter, test strips, Startup Portable Blood Glucose Meter System. Includes: blood glucose meter, test strips, IFU
Catalog Number
-
Brand Name
GLUCOCARD® Shine XL Blood Glucose Monitoring System
Version/Model Number
542199
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
Yes
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
Product Code
CGA
Product Code Name
Glucose Oxidase, Glucose
Public Device Record Key
3ac1e45d-edf3-4455-a866-deab05800901
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 12, 2017
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 |