Dexcom CLARITY 350-0011

GUDID B059CLARITY35000011

Dexcom CLARITY software, web-based data management product is intended for use by both patients and healthcare professionals to assist people with dia

SWEETSPOT DIABETES CARE, INC.

Noninvasive interstitial-fluid glucose monitoring system Noninvasive interstitial-fluid glucose monitoring system Noninvasive interstitial-fluid glucose monitoring device Noninvasive interstitial-fluid glucose monitoring device Noninvasive interstitial-fluid glucose monitoring device Noninvasive interstitial-fluid glucose monitoring device Noninvasive interstitial-fluid glucose monitoring device Noninvasive interstitial-fluid glucose monitoring device Noninvasive interstitial-fluid glucose monitoring device Noninvasive interstitial-fluid glucose monitoring device Noninvasive interstitial-fluid glucose monitoring device Noninvasive interstitial-fluid glucose monitoring device Noninvasive interstitial-fluid glucose monitoring device Noninvasive interstitial-fluid glucose monitoring device Noninvasive interstitial-fluid glucose monitoring device Noninvasive interstitial-fluid glucose monitoring device Noninvasive interstitial-fluid glucose monitoring device Noninvasive interstitial-fluid glucose monitoring device Noninvasive interstitial-fluid glucose monitoring device Noninvasive interstitial-fluid glucose monitoring device Noninvasive interstitial-fluid glucose monitoring device Noninvasive interstitial-fluid glucose monitoring device Noninvasive interstitial-fluid glucose monitoring device Noninvasive interstitial-fluid glucose monitoring device Noninvasive interstitial-fluid glucose monitoring device Noninvasive interstitial-fluid glucose monitoring device

Primary Device ID	B059CLARITY35000011
NIH Device Record Key	314065cc-95ee-4485-b777-299fc28199cc
Commercial Distribution Discontinuation	2016-12-19
Commercial Distribution Status	Not in Commercial Distribution
Brand Name	Dexcom CLARITY
Version Model Number	350-0011
Catalog Number	350-0011
Company DUNS	963889204
Company Name	SWEETSPOT DIABETES CARE, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B059CLARITY35000011 [Primary]

FDA Product Code

PHV	Continuous Glucose Monitor Retrospective Data Analysis Software

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	2
Public Version Date	2018-03-29
Device Publish Date	2016-08-26

Devices Manufactured by SWEETSPOT DIABETES CARE, INC.

B059CLARITY35000011 - Dexcom CLARITY	2018-03-29Dexcom CLARITY software, web-based data management product is intended for use by both patients and healthcare professionals to assist people with dia
B059CLARITY35000011 - Dexcom CLARITY	2018-03-29 Dexcom CLARITY software, web-based data management product is intended for use by both patients and healthcare professionals to
B059DMS3500003 - DATA MANAGEMENT SYSTEM	2018-03-29 Software-as-a-Service Diabetes Data Management Service. System extracts information from BGMs and formats reports of the blood
B059POW3500010 - Dexcom Portrait on the Web	2018-03-29 Data management reporting software use for Dexcom Continuous Glucose Monitoring devices.