AccessGUDID - DEVICE: DATA MANAGEMENT SYSTEM (B059DMS3500003)

GUDID

Device Identifier (DI) Information

Brand Name: DATA MANAGEMENT SYSTEM
Version or Model: 350-0003
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: SSDMS
Company Name: SWEETSPOT DIABETES CARE, INC.

Primary DI Number: B059DMS3500003
Issuing Agency: HIBCC
Commercial Distribution End Date: December 31, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 963889204 *Terms of Use

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

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
NBW	System, Test, Blood Glucose, Over The Counter

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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: 01452f7e-bfb7-4100-b7e0-c1606615c863
Public Version Date: November 28, 2022
Public Version Number: 4
DI Record Publish Date: August 26, 2016