Leader

FDA UDI

Class II (US FDA UDI)

by Cardinal Health 110, Inc.

Identity

Trade Name: LEADER FDA UDI
Generic Name: Glucose monitoring system IVD, home-use FDA UDI
Device Name: Interior package vial label for 50 ct test strips FDA UDI
Model / Reference: 50CTVIAL FDA UDI
Description: Interior package vial label for 50 ct test strips FDA UDI

Identifiers

Catalog Number: 50CTVIAL FDA UDI
Primary DI / UDI-DI: 20096295129162 FDA UDI
FDA Product Code: CGA FDA UDI
GMDN Term: Glucose monitoring system IVD, home-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1345 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Glucose monitoring system IVD, home-use

Leader by Cardinal Health 110, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Glucose monitoring system IVD, home-use.

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ReliOn® Confirm/micro Blood Glucose Test Strips — Walmart Stores · Class II
CONTOUR® NEXT — ASCENSIA DIABETES CARE US INC. · Class II
CareSens N Voice Multi — i-SENS, Inc. · Class II
Oh'Care Lite — IJDREAM CORPORATION · Class I

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: Cardinal Health 110, Inc.

Sources (1)

FDA UDI 07849912-d888-43ca-a93a-57b2f1f35f9b 36 fields · synced Jun 1, 2026