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On Call Express Blood Glucose Monitoring System

FDA UDI

Class I (US FDA UDI)

by ACON Laboratories, Inc.

Identity

Trade Name
On Call Express Blood Glucose Monitoring System FDA UDI
Generic Name
Glucose monitoring system IVD, point-of-care FDA UDI
Device Name
Blood Glucose Monitoring System includes Meter, vial of 10 strips, 2mL bottle of Control 1, lancing device, 10 lancets (30G) FDA UDI
Model / Reference
G115-10D FDA UDI
Description
Blood Glucose Monitoring System includes Meter, vial of 10 strips, 2mL bottle of Control 1, lancing device, 10 lancets (30G) FDA UDI

Identifiers

Primary DI / UDI-DI
00682607557158 FDA UDI
FDA Product Code
JJX FDA UDI
NBW FDA UDI
CGA FDA UDI
GMDN Term
Glucose monitoring system IVD, point-of-care FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1660 FDA UDI
862.1345 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

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

Yes

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Glucose monitoring system IVD, home-useGlucose monitoring system IVD, point-of-care

On Call Express Blood Glucose Monitoring System by ACON Laboratories, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Glucose monitoring system IVD, point-of-care.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
ACON Laboratories, Inc.

Sources (1)

  • FDA UDI d5fe2978-9b9d-43c9-9333-564b8ba32f9c 35 fields · synced Jun 9, 2026