Duns Number:123160736
Device Description: G6 Sensor Applicator Assembly
Catalog Number
-
Brand Name
Dexcom G6 Sensor Applicator Assembly
Version/Model Number
9500-45
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
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
DEN170088,DEN170088,DEN170088,DEN170088,DEN170088
Product Code
QBJ
Product Code Name
Integrated Continuous Glucose Monitoring System, Factory Calibrated
Public Device Record Key
a89e24e1-d6da-4180-8147-e6d286ac6a72
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
April 25, 2018
Package DI Number
50386270000250
Quantity per Package
3
Contains DI Package
00386270000255
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |
| 3 | A medical device with high risk that requires premarket approval | 72 |