Duns Number:123160736
Device Description: Sensor Kit 1 Pack US
Catalog Number
-
Brand Name
Dexcom G4 Platinum Sensor Kit 1PK US
Version/Model Number
STS-GL-011
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
P120005
Product Code
MDS
Product Code Name
Sensor, Glucose, Invasive
Public Device Record Key
276645c2-4c46-481c-8370-6d29e6b42451
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
September 10, 2014
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 | 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 |