Identity
- Trade Name
- Insulin Insights™ FDA UDI
- Generic Name
- Clinical management support software FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- Version 1 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860001009804 FDA UDI
- 510(k) Number
- K160673 FDA UDI
- FDA Product Code
- NDC FDA UDI
- GMDN Term
- Clinical management support software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.1890 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Clinical management support software
Insulin Insights™ by Mellitus Health, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Clinical management support software.
- DentalMonitoring - Smile Doctors — Dental Monitoring · Class II
- SIR-Spheres® Microspheres Activity Calculator (SMAC) — SIRTEX MEDICAL PTY LTD · Class II
- AWARE — Ambient Clinical Analytics · Class II
- BioDashboard — BIOINTELLISENSE, INC. · Class II
- Vinehealth Cancer Companion — VINEHEALTH DIGITAL LIMITED · Class I
- Glooko Mobile Insulin Dosing (MIDS) on Glooko WebDashboard — Glooko, Inc. · Class II
- Vios Monitoring System Central Station Monitor — Murata Vios, Inc. · Class I
- Vios Monitoring System Mobile Application — Murata Vios, Inc. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Mellitus Health, Inc.
Sources (1)
- FDA UDI 6351040a-4673-44d2-a996-a540d4523e8a 35 fields · synced May 30, 2026