| Primary Device ID | B553202202OTC0 |
| NIH Device Record Key | 8f23ff9f-9a5c-44d5-b516-3c963c39eecb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Lilly Health Personalized Medicine and Health Platform |
| Version Model Number | 1.X |
| Company DUNS | 021217115 |
| Company Name | WELLDOC, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B553202202OTC0 [Primary] |
| NXQ | Reminder, Medication |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-06-05 |
| Device Publish Date | 2025-05-28 |
| B553202401OTC0 - Welldoc Rx | 2025-12-17 Welldoc Diabetes is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have t |
| B553202402RX0 - Welldoc Rx | 2025-12-17 Welldoc Diabetes is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have t |
| B553202403OTC0 - Welldoc Rx | 2025-12-17 Welldoc Diabetes is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have t |
| B553202404RX0 - Welldoc Rx | 2025-12-17 Welldoc Diabetes is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have t |
| B553202405RX0 - Welldoc Rx | 2025-12-17 Welldoc Diabetes is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have t |
| B553202406OTC0 - Welldoc Rx App for Diabetes in Pregnancy and Insulin Pump Users | 2025-12-17 The Welldoc Rx App for Diabetes in Pregnancy and Insulin Pump Users (the software) is Software as a Medical Device (SaMD) intend |
| B553202407OTC0 - Welldoc Rx App for Diabetes in Pregnancy and Insulin Pump Users | 2025-12-17 The Welldoc Rx App for Diabetes in Pregnancy and Insulin Pump Users (the software) is Software as a Medical Device (SaMD) intend |
| B553202301OTC0 - Welldoc | 2025-07-29 The Welldoc App is Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCP) and their patients – |