Duns Number:781100966
Device Description: Blood Glucose Meter, 10 test strips, 2mL bottle of Control 1, lancing device, 10 lancets ( Blood Glucose Meter, 10 test strips, 2mL bottle of Control 1, lancing device, 10 lancets (30G)
Catalog Number
757107
Brand Name
On Call Express II Glucose Monitoring System
Version/Model Number
G117-10A
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
K192175,K192175,K192175,K192175
Product Code
NBW
Product Code Name
System, test, blood glucose, over the counter
Public Device Record Key
fe23e44f-854c-464d-a33f-0b30d2253be5
Public Version Date
September 14, 2020
Public Version Number
2
DI Record Publish Date
December 16, 2019
Package DI Number
10682607571076
Quantity per Package
4
Contains DI Package
00682607571079
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 9 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |