gudid Primary ID: OGM-511

ON CALL SURE GK BLOOD GLUCOSE & KETONE MONITORING SYSTEM (UDI OGM-511)

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The ON CALL SURE GK BLOOD GLUCOSE & KETONE MONITORING SYSTEM (Model/Catalog Number: OGM-511) is a medical device manufactured by Acon Laboratories, Inc.. This product is indexed under FDA Product Code / Category Classification NBW within international Unique Device Identification (UDI) compliance databases.

ACTIVE SAFETY RECALL ALERT 1 Event(s) Found

Enforcement actions are currently active for this product line.

ID: Z-2322-2015 View Full Alert →

Mission -Breath Alcohol Detector -15 tests - 0.08% BAC - Blow bags included Product Usage: The Breath Alcohol Detector is for the...

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Technical Specifications

Model Number: OGM-511
Product Code / EMDN: NBW
Device Name: On Call Sure GK Blood Glucose & Ketone Meter (1), On Call Sure Blood Glucose Test Strips (10), On Call Sure Blood Ketone Test Strips (10), On Call Sure Glucose Control Solution 1 (1), On Call Sure Ketone Control Solution 1 (1), Sterile Lancets (10), Lancing Device (1), Carrying Case (1), User's Manual (1), Quick Reference Guide (1), Quick Start Guide (1), Warranty Card (1), Logbook (1)
Database Sync Date: 2026-08-09 10:25:48

Full Regulatory Attributes

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{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}

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Frequently Asked Questions

Who is the primary manufacturer of ON CALL SURE GK BLOOD GLUCOSE & KETONE MONITORING SYSTEM?

The registered manufacturer of record for ON CALL SURE GK BLOOD GLUCOSE & KETONE MONITORING SYSTEM is Acon Laboratories, Inc..

What is the Primary UDI-DI identifier for ON CALL SURE GK BLOOD GLUCOSE & KETONE MONITORING SYSTEM?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is OGM-511.

What classification code is assigned to this device?

This device is registered under product classification code NBW.

Similar Classification Devices (NBW)

Other Devices by Acon Laboratories, Inc.

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