DATA MANAGEMENT SYSTEM SSDMS

GUDID B059DMS3500003

Software-as-a-Service Diabetes Data Management Service. System extracts information from BGMs and formats reports of the blood glucose data.

SWEETSPOT DIABETES CARE, INC.

Noninvasive interstitial-fluid glucose monitoring system

• Primary Device ID: B059DMS3500003
• NIH Device Record Key: 01452f7e-bfb7-4100-b7e0-c1606615c863
• Commercial Distribution Discontinuation: 2016-12-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: DATA MANAGEMENT SYSTEM
• Version Model Number: 350-0003
• Catalog Number: SSDMS
• Company DUNS: 963889204
• Company Name: SWEETSPOT DIABETES CARE, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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	B059DMS3500003 [Primary]

FDA Product Code

• NBW: System, Test, Blood Glucose, Over The Counter

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: 2018-03-29 Dexcom CLARITY software, web-based data management product is intended for use by both patients and healthcare professionals to
• B059DMS3500003 - DATA MANAGEMENT SYSTEM: 2018-03-29Software-as-a-Service Diabetes Data Management Service. System extracts information from BGMs and formats reports of the blood glucose data.
• 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.