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

• 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.