AccessGUDID - DEVICE: Dexcom CLARITY (B059CLARITY35000011)

GUDID

Device Identifier (DI) Information

Brand Name: Dexcom CLARITY
Version or Model: 350-0011
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 350-0011
Company Name: SWEETSPOT DIABETES CARE, INC.

Primary DI Number: B059CLARITY35000011
Issuing Agency: HIBCC
Commercial Distribution End Date: December 19, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 963889204 *Terms of Use

Device Description: Dexcom CLARITY software, web-based data management product is intended for use by both patients and healthcare professionals to assist people with diabetes in the review, analysis and evaluation of historical CGM data to support effective diabetes management. It is intended for use as an accessory to CGM devices with data interface capabilities. With RCP, it provides additional administrative features for use by Clinicians to access Dexcom CLARITY reports (digital or print) for their patients with diabetes. These features do not change the intended use of CLARITY. They improve the usefulness of it from the clinician perspective.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
59231	Noninvasive interstitial-fluid glucose monitoring device	An electrically-powered, noninvasive, portable device designed to continuously measure and record interstitial-fluid glucose concentrations, typically for detecting trends and tracking patterns in a patient with diabetes mellitus. It includes a monitor with optical sensor that measures interstitial glucose concentrations using Raman spectroscopy, and a display which can be a dedicated electronic device or a software application that runs on portable electronics (e.g., smartphone). It may be used in the home and clinical setting, and aids in the detection of episodes of hyperglycaemia and hypoglycaemia, facilitating acute/long-term therapy adjustments.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PHV	Continuous Glucose Monitor Retrospective Data Analysis Software

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 314065cc-95ee-4485-b777-299fc28199cc
Public Version Date: November 28, 2022
Public Version Number: 4
DI Record Publish Date: August 26, 2016