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Cornerstones4Care® Powered by Glooko Mobile Application

FDA UDIEUDAMED

Class I (US FDA UDI)

by Glooko, Inc.

Identity

Trade Name
Cornerstones4Care® Powered by Glooko Mobile Application FDA UDI
Generic Name
Clinical management support software FDA UDI
Device Name
Cornerstones4Care® Powered by Glooko Mobile Application displays and analyzes retrospective data from blood glucose meters, insulin pumps and continuous glucose monitors FDA UDI
Model / Reference
1.xx FDA UDI
Description
Cornerstones4Care® Powered by Glooko Mobile Application displays and analyzes retrospective data from blood glucose meters, insulin pumps and continuous glucose monitors FDA UDI

Identifiers

Primary DI / UDI-DI
00855093008040 FDA UDI
FDA Product Code
PHV FDA UDI
GMDN Term
Clinical management support software FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.2120 FDA UDI
Commercial Distribution
Not 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

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Cornerstones4Care® Powered by Glooko Mobile Application by Glooko, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Glooko, Inc.

Sources (2)

  • FDA UDI 9cbe91e0-519c-4f53-8639-0e89d67068c1 34 fields · synced Jun 18, 2026
  • EUDAMED 1 fields · synced Jun 2, 2026