Plus - The Plus System is indicated for use by - WELLDOC, INC.

Duns Number:021217115

Device Description: The Plus System is indicated for use by healthcare providers (HCPs) and their patients – a The Plus System is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. The Plus System is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. The Plus System analyzes and reports blood glucose test results and supports medication adherence. In addition, the Plus System provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or inprofessional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information.The Plus System is not intended to replace the care provided by a licensed healthcare professional, includingprescriptions, diagnosis, or treatment.

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More Product Details

Catalog Number

-

Brand Name

Plus

Version/Model Number

v1.1

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 23, 2021

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K190013

Product Code Details

Product Code

MRZ

Product Code Name

Accessories, Pump, Infusion

Device Record Status

Public Device Record Key

c8a93fce-1e91-4fde-8cad-a26fbe751257

Public Version Date

October 24, 2022

Public Version Number

3

DI Record Publish Date

June 28, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"WELLDOC, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 56