Welldoc
GUDID B553WELLDOCRX120
Welldoc Diabetes Rx is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. Welldoc Diabetes Rx is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. Welldoc Diabetes Rx analyzes and reports blood glucose test results and supports medication adherence. In addition, Welldoc Diabetes Rx 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. Welldoc Diabetes Rx includes an insulin dose calculator to allow patients to use their prescribed regimen to calculate a dose of bolus insulin for a given amount of carbohydrates and/or blood glucose value. Welldoc Diabetes Rx is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment. Welldoc also includes other functions that are designed to maintain, encourage a healthy lifestyle or help users manage their disease or condition without providing specific treatment or treatment suggestions.
WELLDOC, INC.
Pharmaceutical management support software, patient-/professional-use| Primary Device ID | B553WELLDOCRX120 |
| NIH Device Record Key | 4f2f45ad-0420-4ce4-8cf8-638e12c0165e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Welldoc |
| Version Model Number | v1.2 |
| 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 | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 1-888-611-4794 |
| connect@welldoc.com | |
| Phone | 1-888-611-4794 |
| connect@welldoc.com | |
| Phone | 1-888-611-4794 |
| connect@welldoc.com | |
| Phone | 1-888-611-4794 |
| connect@welldoc.com | |
| Phone | 1-888-611-4794 |
| connect@welldoc.com | |
| Phone | 1-888-611-4794 |
| connect@welldoc.com | |
| Phone | 1-888-611-4794 |
| connect@welldoc.com | |
| Phone | 1-888-611-4794 |
| connect@welldoc.com | |
| Phone | 1-888-611-4794 |
| connect@welldoc.com | |
| Phone | 1-888-611-4794 |
| connect@welldoc.com | |
| Phone | 1-888-611-4794 |
| connect@welldoc.com | |
| Phone | 1-888-611-4794 |
| connect@welldoc.com | |
| Phone | 1-888-611-4794 |
| connect@welldoc.com | |
| Phone | 1-888-611-4794 |
| connect@welldoc.com | |
| Phone | 1-888-611-4794 |
| connect@welldoc.com | |
| Phone | 1-888-611-4794 |
| connect@welldoc.com | |
| Phone | 1-888-611-4794 |
| connect@welldoc.com | |
| Phone | 1-888-611-4794 |
| connect@welldoc.com | |
| Phone | 1-888-611-4794 |
| connect@welldoc.com | |
| Phone | 1-888-611-4794 |
| connect@welldoc.com | |
| Phone | 1-888-611-4794 |
| connect@welldoc.com | |
| Phone | 1-888-611-4794 |
| connect@welldoc.com | |
| Phone | 1-888-611-4794 |
| connect@welldoc.com | |
| Phone | 1-888-611-4794 |
| connect@welldoc.com | |
| Phone | 1-888-611-4794 |
| connect@welldoc.com | |
| Phone | 1-888-611-4794 |
| connect@welldoc.com | |
| Phone | 1-888-611-4794 |
| connect@welldoc.com | |
| Phone | 1-888-611-4794 |
| connect@welldoc.com | |
| Phone | 1-888-611-4794 |
| connect@welldoc.com | |
| Phone | 1-888-611-4794 |
| connect@welldoc.com | |
| Phone | 1-888-611-4794 |
| connect@welldoc.com | |
| Phone | 1-888-611-4794 |
| connect@welldoc.com | |
| Phone | 1-888-611-4794 |
| connect@welldoc.com | |
| Phone | 1-888-611-4794 |
| connect@welldoc.com | |
| Phone | 1-888-611-4794 |
| connect@welldoc.com | |
| Phone | 1-888-611-4794 |
| connect@welldoc.com | |
| Phone | 1-888-611-4794 |
| connect@welldoc.com | |
| Phone | 1-888-611-4794 |
| connect@welldoc.com | |
| Phone | 1-888-611-4794 |
| connect@welldoc.com | |
| Phone | 1-888-611-4794 |
| connect@welldoc.com | |
| Phone | 1-888-611-4794 |
| connect@welldoc.com | |
| Phone | 1-888-611-4794 |
| connect@welldoc.com | |
| Phone | 1-888-611-4794 |
| connect@welldoc.com | |
| Phone | 1-888-611-4794 |
| connect@welldoc.com | |
| Phone | 1-888-611-4794 |
| connect@welldoc.com | |
| Phone | 1-888-611-4794 |
| connect@welldoc.com | |
| Phone | 1-888-611-4794 |
| connect@welldoc.com | |
| Phone | 1-888-611-4794 |
| connect@welldoc.com | |
| Phone | 1-888-611-4794 |
| connect@welldoc.com | |
| Phone | 1-888-611-4794 |
| connect@welldoc.com | |
| Phone | 1-888-611-4794 |
| connect@welldoc.com | |
| Phone | 1-888-611-4794 |
| connect@welldoc.com | |
| Phone | 1-888-611-4794 |
| connect@welldoc.com | |
| Phone | 1-888-611-4794 |
| connect@welldoc.com | |
| Phone | 1-888-611-4794 |
| connect@welldoc.com | |
| Phone | 1-888-611-4794 |
| connect@welldoc.com | |
| Phone | 1-888-611-4794 |
| connect@welldoc.com | |
| Phone | 1-888-611-4794 |
| connect@welldoc.com | |
| Phone | 1-888-611-4794 |
| connect@welldoc.com | |
| Phone | 1-888-611-4794 |
| connect@welldoc.com | |
| Phone | 1-888-611-4794 |
| connect@welldoc.com | |
| Phone | 1-888-611-4794 |
| connect@welldoc.com | |
| Phone | 1-888-611-4794 |
| connect@welldoc.com | |
| Phone | 1-888-611-4794 |
| connect@welldoc.com | |
| Phone | 1-888-611-4794 |
| connect@welldoc.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B553WELLDOCRX120 [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 | 2022-04-22 |
| Device Publish Date | 2022-04-14 |
On-Brand Devices [Welldoc]
| B553WELLDOC100 | Welldoc Diabetes is indicated for use by healthcare providers (HCPs) and their patients – aged |
| B553WELLDOC110 | Welldoc Diabetes is indicated for use by healthcare providers (HCPs) and their patients – aged |
| B553WELLDOCRX120 | Welldoc Diabetes Rx is indicated for use by healthcare providers (HCPs) and their patients – a |
| B553WELLDOC120 | Welldoc Diabetes is indicated for use by healthcare providers (HCPs) and their patients – aged |
| B553WELLDOCRX130 | Welldoc Diabetes Rx is indicated for use by healthcare providers (HCPs) and their patients – a |
| B553WELLDOC130 | Welldoc Diabetes is indicated for use by healthcare providers (HCPs) and their patients – aged |
| B553WELLDOCRX140 | Welldoc Diabetes Rx is indicated for use by healthcare providers (HCPs) and their patients – a |
| B553WELLDOC140 | Welldoc Diabetes is indicated for use by healthcare providers (HCPs) and their patients – aged |
| B553WELLDOCRX200 | Welldoc Diabetes is indicated for use by healthcare providers (HCPs) and their patients – aged |
| B553WELLDOC200 | Welldoc Diabetes is indicated for use by healthcare providers (HCPs) and their patients – aged |
| B553202056RX0 | Welldoc Diabetes is indicated for use by healthcare providers (HCPs) and their patients – aged |
| B553202054RX0 | Welldoc Diabetes is indicated for use by healthcare providers (HCPs) and their patients – aged |
| B553202053OTC0 | Welldoc Diabetes is indicated for use by healthcare providers (HCPs) and their patients – aged |
| B553202052RX0 | Welldoc Diabetes is indicated for use by healthcare providers (HCPs) and their patients – aged |
| B553202051OTC0 | Welldoc Diabetes is indicated for use by healthcare providers (HCPs) and their patients – aged |
| B553202256RX0 | Welldoc Diabetes is indicated for use by healthcare providers (HCPs) and their patients – aged |
| B553202254RX0 | Welldoc Diabetes is indicated for use by healthcare providers (HCPs) and their patients – aged |
| B553202253OTC0 | Welldoc Diabetes is indicated for use by healthcare providers (HCPs) and their patients – aged |
| B553202252RX0 | Welldoc Diabetes is indicated for use by healthcare providers (HCPs) and their patients – aged |
| B553202251OTC0 | Welldoc Diabetes is indicated for use by healthcare providers (HCPs) and their patients – aged |
| B553202303OTC0 | The Welldoc App is Software as a Medical Device (SaMD) intended to be used by healthcare provide |
| B553202302OTC0 | The Welldoc App is Software as a Medical Device (SaMD) intended to be used by healthcare provide |
| B553202301OTC0 | The Welldoc App is Software as a Medical Device (SaMD) intended to be used by healthcare provide |
Trademark Results [Welldoc]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 WELLDOC 88808718 not registered Live/Pending |
Welldoc, Inc. 2020-02-24 |
 WELLDOC 77115970 3534689 Live/Registered |
WellDoc Communications, Inc. 2007-02-26 |
 WELLDOC 76692952 4206117 Live/Registered |
WELLDOC, INC. 2008-09-18 |
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