Dexcom CLARITY - Dexcom CLARITY software, web-based data - SWEETSPOT DIABETES CARE, INC.

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.

Want to know more about this Product? Request more information now!


More Product Details

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

Product Characteristics

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 Details

Product Code

PHV

Product Code Name

Continuous Glucose Monitor Retrospective Data Analysis Software

Device Record Status

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

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SWEETSPOT DIABETES CARE, INC." Characteristics
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