Plus
GUDID B553PLUS100
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 in professional 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, including prescriptions, diagnosis, or treatment.
WELLDOC, INC.
Pharmaceutical management support software, patient-/professional-use Pharmaceutical management support software, patient-/professional-use Pharmaceutical management support software, patient-/professional-use Pharmaceutical management support software, patient-/professional-use Pharmaceutical management support software, patient-/professional-use Pharmaceutical management support software, patient-/professional-use Pharmaceutical management support software, patient-/professional-use Pharmaceutical management support software, patient-/professional-use Pharmaceutical management support software, patient-/professional-use Pharmaceutical management support software, patient-/professional-use Pharmaceutical management support software, patient-/professional-use Pharmaceutical management support software, patient-/professional-use Pharmaceutical management support software, patient-/professional-use Pharmaceutical management support software, patient-/professional-use Pharmaceutical management support software, patient-/professional-use Pharmaceutical management support software, patient-/professional-use Pharmaceutical management support software, patient-/professional-use Pharmaceutical management support software, patient-/professional-use Pharmaceutical management support software, patient-/professional-use Pharmaceutical management support software, patient-/professional-use Pharmaceutical management support software, patient-/professional-use Pharmaceutical management support software, patient-/professional-use Pharmaceutical management support software, patient-/professional-use Pharmaceutical management support software, patient-/professional-use Pharmaceutical management support software, patient-/professional-use Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software| Primary Device ID | B553PLUS100 |
| NIH Device Record Key | 41e4c873-7b28-4eec-9a50-631f9171f96f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Plus |
| Version Model Number | v1.0 |
| Company DUNS | 021217115 |
| Company Name | WELLDOC, 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 | false |
| 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 | true |
Customer Support Contacts
| Phone | 1-888-450-3664 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
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| Phone | 1-888-450-3664 |
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| Phone | 1-888-450-3664 |
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| Phone | 1-888-450-3664 |
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| Phone | 1-888-450-3664 |
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| Phone | 1-888-450-3664 |
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| Phone | 1-888-450-3664 |
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| Phone | 1-888-450-3664 |
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| Phone | 1-888-450-3664 |
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| Phone | 1-888-450-3664 |
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| Phone | 1-888-450-3664 |
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| Phone | 1-888-450-3664 |
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| Phone | 1-888-450-3664 |
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| Phone | 1-888-450-3664 |
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| Phone | 1-888-450-3664 |
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| Phone | 1-888-450-3664 |
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| Phone | 1-888-450-3664 |
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| Phone | 1-888-450-3664 |
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| Phone | 1-888-450-3664 |
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| Phone | 1-888-450-3664 |
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| Phone | 1-888-450-3664 |
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| Phone | 1-888-450-3664 |
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| Phone | 1-888-450-3664 |
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| Phone | 1-888-450-3664 |
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| Phone | 1-888-450-3664 |
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| Phone | 1-888-450-3664 |
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| Phone | 1-888-450-3664 |
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| Phone | 1-888-450-3664 |
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| Phone | 1-888-450-3664 |
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| Phone | 1-888-450-3664 |
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| Phone | 1-888-450-3664 |
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| Phone | 1-888-450-3664 |
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| Phone | 1-888-450-3664 |
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| Phone | 1-888-450-3664 |
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| Phone | 1-888-450-3664 |
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| Phone | 1-888-450-3664 |
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| Phone | 1-888-450-3664 |
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| Phone | 1-888-450-3664 |
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| Phone | 1-888-450-3664 |
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| Phone | 1-888-450-3664 |
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| Phone | 1-888-450-3664 |
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| Phone | 1-888-450-3664 |
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| Phone | 1-888-450-3664 |
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| Phone | 1-888-450-3664 |
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| Phone | 1-888-450-3664 |
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| Phone | 1-888-450-3664 |
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| Phone | 1-888-450-3664 |
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| Phone | 1-888-450-3664 |
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| Phone | 1-888-450-3664 |
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| Phone | 1-888-450-3664 |
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| Phone | 1-888-450-3664 |
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| Phone | 1-888-450-3664 |
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| Phone | 1-888-450-3664 |
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| Phone | 1-888-450-3664 |
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| Phone | 1-888-450-3664 |
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| Phone | 1-888-450-3664 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
| connect@welldoc.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B553PLUS100 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K190013
FDA Product Code
| MRZ | Accessories, Pump, Infusion |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-12-03 |
| Device Publish Date | 2020-11-25 |
On-Brand Devices [Plus]
| B553PLUS100 | The Plus System is indicated for use by healthcare providers (HCPs) and their patients – aged |
| B553PLUS110 | The Plus System is indicated for use by healthcare providers (HCPs) and their patients – aged |
| B553PLUS120 | The Plus System is indicated for use by healthcare providers (HCPs) and their patients – aged |
Trademark Results [Plus]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PLUS 98468014 not registered Live/Pending |
Omega Yeast Labs, LLC 2024-03-26 |
 PLUS 97860481 not registered Live/Pending |
MCGRAW HILL LLC 2023-03-28 |
 PLUS 97842338 not registered Live/Pending |
CLARK CORE SERVICES, LLC 2023-03-16 |
 PLUS 97453862 not registered Live/Pending |
PlusAI, Inc. 2022-06-10 |
 PLUS 97369344 not registered Live/Pending |
Holmes, Murphy and Associates, LLC 2022-04-19 |
 PLUS 97139608 not registered Live/Pending |
PlusAI, Inc. 2021-11-23 |
 PLUS 97137842 not registered Live/Pending |
PlusAI, Inc. 2021-11-22 |
 PLUS 97016612 not registered Live/Pending |
ACTIVA Products Inc. 2021-09-08 |
 PLUS 90746349 not registered Live/Pending |
PlusAI, Inc. 2021-06-01 |
 PLUS 90746338 not registered Live/Pending |
PlusAI, Inc. 2021-06-01 |
 PLUS 90652885 not registered Live/Pending |
SpeedFind, Inc. 2021-04-17 |
 PLUS 90364343 not registered Live/Pending |
Hayhurst, James L. 2020-12-07 |
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