Duns Number:108359188
Device Description: Glucose Meter Accessory for existing glucose meters from LifeScan, providing Bluetooth 2. Glucose Meter Accessory for existing glucose meters from LifeScan, providing Bluetooth 2.1 connectivity for telehealth applications. This is built on a PWR-09-02 device, which an also support other glucose meter families if appropriate cables are provided:"B" cable: Bayer Breeze2, Contour, Contour TS, Contour XT, Contour next EZ,"A" cable: Abbott FreeStyle Lite, FreeStyle Freedom Lite
Catalog Number
-
Brand Name
Polytel
Version/Model Number
GMA2-L
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OUG
Product Code Name
Medical Device Data System
Public Device Record Key
d8d0b17a-8c68-4eb0-811b-5f4920ae662a
Public Version Date
November 10, 2021
Public Version Number
4
DI Record Publish Date
March 08, 2017
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 |