Duns Number:185067774
Device Description: Glucopad Blood Glucose Monitoring System (BGMS) is for self testing use and it consists of Glucopad Blood Glucose Monitoring System (BGMS) is for self testing use and it consists of a blood glucose meter, and blood glucose test strips.
Catalog Number
G852-C-001
Brand Name
TECO DIAGNOSTICS
Version/Model Number
Glucopad Blood Glucose Monitoring System
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K111456
Product Code
CGA
Product Code Name
Glucose Oxidase, Glucose
Public Device Record Key
a5690989-201c-40b0-801c-a56300e50e43
Public Version Date
August 17, 2022
Public Version Number
1
DI Record Publish Date
August 09, 2022
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 | 51 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 11 |