← Back to catalogue
Glooko Mobile Insulin Dosing (MIDS) on Glooko WebDashboard
FDA UDIClass II (US FDA UDI)
by Glooko, Inc.
Identity
- Trade Name
- Glooko Mobile Insulin Dosing (MIDS) on Glooko WebDashboard FDA UDI
- Generic Name
- Clinical management support software FDA UDI
- Device Name
- Glooko Mobile Insulin Dosing System is an insulin dose calculator. The Glooko MIDS Web software is available for use by the prescribers on standard web browsers. FDA UDI
- Model / Reference
- 18.x FDA UDI
- Description
- Glooko Mobile Insulin Dosing System is an insulin dose calculator. The Glooko MIDS Web software is available for use by the prescribers on standard web browsers. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00855093008019 FDA UDI
- 510(k) Number
- K171450 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
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Clinical management support software
Glooko Mobile Insulin Dosing (MIDS) on Glooko WebDashboard by Glooko, 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
- Vios Monitoring System Central Station Monitor — Murata Vios, Inc. · Class I
- Vios Monitoring System Mobile Application — Murata Vios, Inc. · Class II
- Magstim Analytics — The Magstim Company , Ltd. · Class I
Cleared under the same submission
K171450 also covers:
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
- Glooko, Inc.
Sources (1)
- FDA UDI c4c7f171-27b9-4d36-82ca-d602653e1f90 34 fields · synced May 31, 2026