GUDIDData
gudid Primary ID: G117-108

On Call Express Voice Blood Glucose Monitoring System (UDI G117-108)

Manufactured by Acon Laboratories, Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for On Call Express Voice Blood Glucose Monitoring System - Primary ID G117-108

Device Regulatory Overview

The On Call Express Voice Blood Glucose Monitoring System (Model/Catalog Number: G117-108) is a medical device manufactured by Acon Laboratories, Inc.. This product is indexed under FDA Product Code / Category Classification JJX 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
G117-108
Product Code / EMDN
JJX
Device Name
Blood Glucose Meter, vial of 10 strips, 2mL bottle of Control 1, lancing device, 10 lancets (30G)
Database Sync Date
2026-08-09 09:17:18

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 Express Voice Blood Glucose Monitoring System?

The registered manufacturer of record for On Call Express Voice Blood Glucose Monitoring System is Acon Laboratories, Inc..

What is the Primary UDI-DI identifier for On Call Express Voice Blood Glucose Monitoring System?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is G117-108.

What classification code is assigned to this device?

This device is registered under product classification code JJX.

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