Duns Number:108359188
Device Description: Glucose meter accessory providing Bluetooth connectivity to glucose meters manufactured by Glucose meter accessory providing Bluetooth connectivity to glucose meters manufactured by Bayer. Specific meters supported are Breeze2, Contour, Contour TS, Contour next EZ.
Catalog Number
-
Brand Name
Polytel GMA
Version/Model Number
PWR-08-07
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)
Yes
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
711355e7-6bdd-47a9-bc82-f37c84d039e9
Public Version Date
November 10, 2021
Public Version Number
4
DI Record Publish Date
August 02, 2016
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 | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |