Duns Number:545852548
Device Description: Blood Glucose Monitoring System, It contains blood glucose meter, blood glucose test strip Blood Glucose Monitoring System, It contains blood glucose meter, blood glucose test strips, lancing device and sterile lancet.
Catalog Number
-
Brand Name
telli health
Version/Model Number
G-427B
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
NBW
Product Code Name
System, Test, Blood Glucose, Over The Counter
Public Device Record Key
5e3f7c79-3659-4a8e-bcc7-f2a5fd11d7d7
Public Version Date
August 20, 2021
Public Version Number
2
DI Record Publish Date
March 08, 2021
Package DI Number
16939184630219
Quantity per Package
10
Contains DI Package
06939184630212
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 11 |