TempoSmart
GUDID B553202173OTC0
TempoSmart™ is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. TempoSmart is intended to assist patients in managing their diabetes with guidance from their providers.
WELLDOC, INC.
Home pharmaceutical management support software| Primary Device ID | B553202173OTC0 |
| NIH Device Record Key | a7ac0408-b4c4-4a61-831f-9b8016f02635 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TempoSmart |
| Version Model Number | 2.X |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B553202173OTC0 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K230813
FDA Product Code
| NDC | Calculator, Drug Dose |
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 | 2024-04-23 |
| Device Publish Date | 2024-04-15 |
On-Brand Devices [TempoSmart]
| B553TEMPOSMART100 | TempoSmart™ is a Software as a Medical Device (SaMD) intended to be used by healthcare provide |
| B553TEMPOSMART110 | TempoSmart™ is a Software as a Medical Device (SaMD) intended to be used by healthcare provide |
| B553202174RX0 | TempoSmart™ is a Software as a Medical Device (SaMD) intended to be used by healthcare provide |
| B553202173OTC0 | TempoSmart™ is a Software as a Medical Device (SaMD) intended to be used by healthcare provide |
| B553202172RX0 | TempoSmart™ is a Software as a Medical Device (SaMD) intended to be used by healthcare provide |
| B553202171OTC0 | TempoSmart™ is a Software as a Medical Device (SaMD) intended to be used by healthcare provide |
Trademark Results [TempoSmart]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TEMPOSMART 90641340 not registered Live/Pending |
Eli Lilly and Company 2021-04-13 |
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