Duns Number:963889204
Device Description: Dexcom CLARITY software, web-based data management product is intendedfor use by both pati Dexcom CLARITY software, web-based data management product is intendedfor use by both patients and healthcare professionals to assist people with diabetes in thereview, analysis and evaluation of historical CGM data to support effective diabetesmanagement. It is intended for use as an accessory to CGM devices with data interfacecapabilities.With RCP, it provides additional administrative features for use by Clinicians toaccess Dexcom CLARITY reports (digital or print) for their patients with diabetes. Thesefeatures do not change the intended use of CLARITY. They improve the usefulness of it fromthe clinician perspective.
Catalog Number
350-0011
Brand Name
Dexcom CLARITY
Version/Model Number
350-0011
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 19, 2016
Issuing Agency
In HIBCC
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
PHV
Product Code Name
Continuous Glucose Monitor Retrospective Data Analysis Software
Public Device Record Key
314065cc-95ee-4485-b777-299fc28199cc
Public Version Date
September 09, 2020
Public Version Number
3
DI Record Publish Date
August 26, 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. | 1 |