Duns Number:781100966
Device Description: Blood Glucose Meter, 100 test strips, 2mL bottle of Control 1, lancing device, 100 lancets Blood Glucose Meter, 100 test strips, 2mL bottle of Control 1, lancing device, 100 lancets (30G)
Catalog Number
757114
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
Product Code
NBW
Product Code Name
System, test, blood glucose, over the counter
Public Device Record Key
538af0e9-d16f-4ed2-aa67-8520c4d5d40c
Public Version Date
September 23, 2020
Public Version Number
1
DI Record Publish Date
September 15, 2020
Package DI Number
20682607571141
Quantity per Package
15
Contains DI Package
00682607571147
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| 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 |