Duns Number:781100966
Device Description: Blood Glucose Meter, vial of 10 strips, 2mL bottle of Control 1, lancing device, 10 lancet Blood Glucose Meter, vial of 10 strips, 2mL bottle of Control 1, lancing device, 10 lancets (30G)
Catalog Number
755012
Brand Name
On Call Express Mobile Blood Glucose Monitoring System
Version/Model Number
G115-10S
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
K180196,K180196,K180196,K180196
Product Code
CGA
Product Code Name
GLUCOSE OXIDASE, GLUCOSE
Public Device Record Key
44f371aa-a704-4005-83b7-14eebd6ac3c1
Public Version Date
December 11, 2019
Public Version Number
2
DI Record Publish Date
June 14, 2019
Package DI Number
10682607550125
Quantity per Package
4
Contains DI Package
00682607550128
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 |