Glooko Mobile Insulin Dosing System (MIDS) Android & iOS Mobile Application

FDA UDI

Class II (US FDA UDI)

by Glooko, Inc.

Identity

Trade Name: Glooko Mobile Insulin Dosing System (MIDS) Android & iOS Mobile Application FDA UDI
Generic Name: Clinical management support software FDA UDI
Device Name: Glooko Mobile Insulin Dosing System (MIDS) is an insulin dose calculator. The Glooko MIDS Mobile Application is only available to patients who have been prescribed MIDS by their heath care provider. The mobile application can be downloaded by patients from the Google Play Store for Android and from the Apple App Store for iOS operating systems. FDA UDI
Model / Reference: 5.x FDA UDI
Description: Glooko Mobile Insulin Dosing System (MIDS) is an insulin dose calculator. The Glooko MIDS Mobile Application is only available to patients who have been prescribed MIDS by their heath care provider. The mobile application can be downloaded by patients from the Google Play Store for Android and from the Apple App Store for iOS operating systems. FDA UDI

Identifiers

Primary DI / UDI-DI: 00855093008002 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

FDA UDI

Single Use

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Implantable

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Contains Latex

Yes

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Prescription Use

Yes

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Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

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Lot / Batch Number

Yes

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Serial Number

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Expiration Date

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Manufacturing Date

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Category: Clinical management support software

Glooko Mobile Insulin Dosing System (MIDS) Android & iOS Mobile Application by Glooko, Inc. — Class II — FDA UDI — listed in FDA GUDID

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Cleared under the same submission

K171450 also covers:

Glooko Mobile Insulin Dosing (MIDS) on Glooko WebDashboard — Glooko, Inc.

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

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Manufacturer

Manufacturer: Glooko, Inc.

Sources (1)

FDA UDI 3eb66960-d617-4339-8dcd-81eaf5b3c445 34 fields · synced May 29, 2026