Duns Number:123160736
Device Description: Data Manager Software
Catalog Number
-
Brand Name
Dexcom Clarity
Version/Model Number
350-0011
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 16, 2019
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
DEN140016
Product Code
PHV
Product Code Name
Continuous Glucose Monitor Retrospective Data Analysis Software
Public Device Record Key
c9f749ea-bdd5-4ada-870c-8345179c514d
Public Version Date
June 10, 2022
Public Version Number
6
DI Record Publish Date
December 20, 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 | 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 |