Insulin Insights™
Insulin Insights™ is a glycemic management software support program designed to provide insulin dosing recommendations to the clinician in order to adjust and maintain blood glucose levels…
Insulin Insights™ is a glycemic management software support program designed to provide insulin dosing recommendations to the clinician in order to adjust and maintain blood glucose levels in insulin-dependent diabetic patients within a clinician determined target range. Insulin Insights™ evaluates a set of current and cumulative patient blood glucose values together with biometric information (including age, weight, height, and gender) and suggests changes (if necessary). Insulin Insights™ is designed for use by healthcare professionals. Insulin Insights™ is indicated for use in adults and pediatric patients ages 7 and above who weigh more than 36 lbs.
Who Else Makes It
All of them in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sanmina | Kunshan | Jiangsu | Contract manufacturer | 15 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
Record
| Listed by | Mellitus Health, Inc. |
|---|---|
| FDA product code | NDC |
| Device type | Calculator, Drug Dose |
| Device class | Class 2 |
| Regulation | 21 CFR 868.1890 |
| 510(k) | K160673 |
| Record published | 2019-10-23 |
| Record revised | 2026-07-21 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Version 1 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Welldoc | Welldoc | 16 |
| Insulia | Voluntis | 6 |
| Healthfirst Cares Rx | Welldoc | 6 |
| Bluestar | Welldoc | 6 |
| Healthfirst Cares | Welldoc | 5 |
| Conifer Connect Diabetes | Welldoc | 5 |
| Welldoc Rx | Welldoc | 5 |
| LivingConnected Diabetes Rx | Welldoc | 5 |
| Bluestar Rx | Welldoc | 5 |
| Conifer Connect Diabetes Rx | Welldoc | 5 |
| inpen™ | Medtronic Minimed | 5 |
| TempoSmart | Welldoc | 4 |
Showing 12 of 36. All products under Calculator, Drug Dose
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.