Duns Number:205155174
Device Description: For use with IDEAL LIFE Gluco-Manager as a quality check to verify accuracy of blood gluco For use with IDEAL LIFE Gluco-Manager as a quality check to verify accuracy of blood glucose test results. The Control Solutions contains a known amount of glucose that reacts with the test strips.
Catalog Number
-
Brand Name
IDEAL LIFE Control Solution Level II
Version/Model Number
GCS0104
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
-
Product Code
CGA
Product Code Name
Glucose Oxidase, Glucose
Public Device Record Key
c57046e2-e176-406b-9c7a-2bb3277d6ce3
Public Version Date
August 08, 2019
Public Version Number
4
DI Record Publish Date
July 17, 2019
Package DI Number
10804084000157
Quantity per Package
200
Contains DI Package
00804084000150
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |